Food Recalls: Essentials for Action Presented By: California Department of Public Heath Food and Drug Branch Phone: (916) 650-6500 Fax: (916) 650-6650 [email protected] 3 4 1 5 1 3 7 1 4 0 2015 1 2017
Food Recalls Essentials for Action
Presented By California Department of Public Heath
Food and Drug Branch
Phone (916) 650-6500 Fax (916) 650-6650 FDBtrainingcdphcagov
3
4
1
5
1
3
7
1
4
0
2015
1
2017
Training Agenda
I Food Safety Law and Regulatory Agencies
II Essential Elements of a Recall Action Plan
III Mock Recall Exercise
IV Resources
California Law Sherman Food Drug and Cosmetic Act
The Sherman Food Drug and Cosmetic Act is the state law that prohibits the manufacture or
sale of food that is adulterated misbranded falsely advertised or misleading
Text of the Sherman Law can be found at httpwwwcdphcagovservicesDocumentsfdbSFDCApdf
Adulteration (Health and Safety Code Sections 110545-110610)
Ways that food can become contaminated or ldquoadulteratedrdquo
Physical Glass ndash jars bottles light fixtures thermometers Metal ndash machinery wire staples Plastic - packaging materials Stones- from plant surroundings Wood ndash boxes bins pallets
Chemical Chemical adulteration includes pesticides cleaners and paint toxic elements such as lead or mercury
Biological Viruses or bacteria from food-borne pathogens (ie Salmonella E coli 0157H7 Hepatitis A)
2
2017
Misbranding THE WHEREBY CLAUSE(Health and Safety Code Section 110660)
Requires that all packaged foods list specific information on labels to avoid misbranding due to false misleading or missing information
Food labels must include Food Name Responsible Firm Address (if not listed in local Yellow Pages) Ingredient Listing (in order of predominance by weight) Net Quantity
Allergen Labeling Law FALCPA
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) applies to all foods labeled on or after January 1 2006
Food labels must list the food source names of all ingredients that contain any protein derived from the eight most common food allergens which FALCPA defines as ldquomajor food allergensrdquo
FALCPA Major Allergens
Eight foods are designated as major food allergens by FALCPA
bull Milk bull Eggs bull Fish (eg bass flounder cod) bull Crustacean shellfish (eg crab lobster shrimp) bull Tree nuts (eg almonds walnuts pecans) bull Peanuts bull Wheat bull Soy
3
2017
Bioterrorism Registration
To protect the public from a threat or actual terrorist attack on the nationrsquos food supply the Public Health Security and Bioterrorism Preparedness Response Act requires food facilities to register with the FDA
Register at wwwfdagov
FSMA Main Themes of the Law
Prevention
Inspections Enhanced Compliance
Partnerships and Response
Import Safety
Proposed Rules
Preventative Controls for Human Food 83015
Preventative Controls for Animal Food 83015
Produce Safety Standards 103115
Foreign Supplier Verification Program 103115
Accreditation of Third Party Auditors 103115
Sanitary Transportation 33116
Intentional Adulteration 53116
4
2017
Food Safety Modernization Act
Check the FDA website at wwwfdagovfsma for information on FSMA
A subscription service for updates is available Contact FSMAfdahhsgov
General Foods
Fresh Produce
Meat amp Poultry
Disease Investigation
Removal of Products fromCommerce
5
2017
Removal of Products from Commerce
Stock Recovery
Market Withdrawal
Recalls
Recalls
Class I Class II Class III
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2 EVALUATE the hazard
3 IDENTIFY product and scope
4 NOTIFY affected parties
5 REMOVE affected product
6
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2
3
4
5
RECALL ACTION PLAN Recall Team
Management
DistributionSales
ProductionPurchasing
Quality Assurance
Recall Coordinator
RECALL ACTION PLAN Support Personnel
Accounting Information Technology
Customer Service Scientific Support
Public Relations Records Management
Legal Regulatory Affairs
7
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Training Agenda
I Food Safety Law and Regulatory Agencies
II Essential Elements of a Recall Action Plan
III Mock Recall Exercise
IV Resources
California Law Sherman Food Drug and Cosmetic Act
The Sherman Food Drug and Cosmetic Act is the state law that prohibits the manufacture or
sale of food that is adulterated misbranded falsely advertised or misleading
Text of the Sherman Law can be found at httpwwwcdphcagovservicesDocumentsfdbSFDCApdf
Adulteration (Health and Safety Code Sections 110545-110610)
Ways that food can become contaminated or ldquoadulteratedrdquo
Physical Glass ndash jars bottles light fixtures thermometers Metal ndash machinery wire staples Plastic - packaging materials Stones- from plant surroundings Wood ndash boxes bins pallets
Chemical Chemical adulteration includes pesticides cleaners and paint toxic elements such as lead or mercury
Biological Viruses or bacteria from food-borne pathogens (ie Salmonella E coli 0157H7 Hepatitis A)
2
2017
Misbranding THE WHEREBY CLAUSE(Health and Safety Code Section 110660)
Requires that all packaged foods list specific information on labels to avoid misbranding due to false misleading or missing information
Food labels must include Food Name Responsible Firm Address (if not listed in local Yellow Pages) Ingredient Listing (in order of predominance by weight) Net Quantity
Allergen Labeling Law FALCPA
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) applies to all foods labeled on or after January 1 2006
Food labels must list the food source names of all ingredients that contain any protein derived from the eight most common food allergens which FALCPA defines as ldquomajor food allergensrdquo
FALCPA Major Allergens
Eight foods are designated as major food allergens by FALCPA
bull Milk bull Eggs bull Fish (eg bass flounder cod) bull Crustacean shellfish (eg crab lobster shrimp) bull Tree nuts (eg almonds walnuts pecans) bull Peanuts bull Wheat bull Soy
3
2017
Bioterrorism Registration
To protect the public from a threat or actual terrorist attack on the nationrsquos food supply the Public Health Security and Bioterrorism Preparedness Response Act requires food facilities to register with the FDA
Register at wwwfdagov
FSMA Main Themes of the Law
Prevention
Inspections Enhanced Compliance
Partnerships and Response
Import Safety
Proposed Rules
Preventative Controls for Human Food 83015
Preventative Controls for Animal Food 83015
Produce Safety Standards 103115
Foreign Supplier Verification Program 103115
Accreditation of Third Party Auditors 103115
Sanitary Transportation 33116
Intentional Adulteration 53116
4
2017
Food Safety Modernization Act
Check the FDA website at wwwfdagovfsma for information on FSMA
A subscription service for updates is available Contact FSMAfdahhsgov
General Foods
Fresh Produce
Meat amp Poultry
Disease Investigation
Removal of Products fromCommerce
5
2017
Removal of Products from Commerce
Stock Recovery
Market Withdrawal
Recalls
Recalls
Class I Class II Class III
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2 EVALUATE the hazard
3 IDENTIFY product and scope
4 NOTIFY affected parties
5 REMOVE affected product
6
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2
3
4
5
RECALL ACTION PLAN Recall Team
Management
DistributionSales
ProductionPurchasing
Quality Assurance
Recall Coordinator
RECALL ACTION PLAN Support Personnel
Accounting Information Technology
Customer Service Scientific Support
Public Relations Records Management
Legal Regulatory Affairs
7
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Misbranding THE WHEREBY CLAUSE(Health and Safety Code Section 110660)
Requires that all packaged foods list specific information on labels to avoid misbranding due to false misleading or missing information
Food labels must include Food Name Responsible Firm Address (if not listed in local Yellow Pages) Ingredient Listing (in order of predominance by weight) Net Quantity
Allergen Labeling Law FALCPA
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) applies to all foods labeled on or after January 1 2006
Food labels must list the food source names of all ingredients that contain any protein derived from the eight most common food allergens which FALCPA defines as ldquomajor food allergensrdquo
FALCPA Major Allergens
Eight foods are designated as major food allergens by FALCPA
bull Milk bull Eggs bull Fish (eg bass flounder cod) bull Crustacean shellfish (eg crab lobster shrimp) bull Tree nuts (eg almonds walnuts pecans) bull Peanuts bull Wheat bull Soy
3
2017
Bioterrorism Registration
To protect the public from a threat or actual terrorist attack on the nationrsquos food supply the Public Health Security and Bioterrorism Preparedness Response Act requires food facilities to register with the FDA
Register at wwwfdagov
FSMA Main Themes of the Law
Prevention
Inspections Enhanced Compliance
Partnerships and Response
Import Safety
Proposed Rules
Preventative Controls for Human Food 83015
Preventative Controls for Animal Food 83015
Produce Safety Standards 103115
Foreign Supplier Verification Program 103115
Accreditation of Third Party Auditors 103115
Sanitary Transportation 33116
Intentional Adulteration 53116
4
2017
Food Safety Modernization Act
Check the FDA website at wwwfdagovfsma for information on FSMA
A subscription service for updates is available Contact FSMAfdahhsgov
General Foods
Fresh Produce
Meat amp Poultry
Disease Investigation
Removal of Products fromCommerce
5
2017
Removal of Products from Commerce
Stock Recovery
Market Withdrawal
Recalls
Recalls
Class I Class II Class III
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2 EVALUATE the hazard
3 IDENTIFY product and scope
4 NOTIFY affected parties
5 REMOVE affected product
6
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2
3
4
5
RECALL ACTION PLAN Recall Team
Management
DistributionSales
ProductionPurchasing
Quality Assurance
Recall Coordinator
RECALL ACTION PLAN Support Personnel
Accounting Information Technology
Customer Service Scientific Support
Public Relations Records Management
Legal Regulatory Affairs
7
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Bioterrorism Registration
To protect the public from a threat or actual terrorist attack on the nationrsquos food supply the Public Health Security and Bioterrorism Preparedness Response Act requires food facilities to register with the FDA
Register at wwwfdagov
FSMA Main Themes of the Law
Prevention
Inspections Enhanced Compliance
Partnerships and Response
Import Safety
Proposed Rules
Preventative Controls for Human Food 83015
Preventative Controls for Animal Food 83015
Produce Safety Standards 103115
Foreign Supplier Verification Program 103115
Accreditation of Third Party Auditors 103115
Sanitary Transportation 33116
Intentional Adulteration 53116
4
2017
Food Safety Modernization Act
Check the FDA website at wwwfdagovfsma for information on FSMA
A subscription service for updates is available Contact FSMAfdahhsgov
General Foods
Fresh Produce
Meat amp Poultry
Disease Investigation
Removal of Products fromCommerce
5
2017
Removal of Products from Commerce
Stock Recovery
Market Withdrawal
Recalls
Recalls
Class I Class II Class III
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2 EVALUATE the hazard
3 IDENTIFY product and scope
4 NOTIFY affected parties
5 REMOVE affected product
6
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2
3
4
5
RECALL ACTION PLAN Recall Team
Management
DistributionSales
ProductionPurchasing
Quality Assurance
Recall Coordinator
RECALL ACTION PLAN Support Personnel
Accounting Information Technology
Customer Service Scientific Support
Public Relations Records Management
Legal Regulatory Affairs
7
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Food Safety Modernization Act
Check the FDA website at wwwfdagovfsma for information on FSMA
A subscription service for updates is available Contact FSMAfdahhsgov
General Foods
Fresh Produce
Meat amp Poultry
Disease Investigation
Removal of Products fromCommerce
5
2017
Removal of Products from Commerce
Stock Recovery
Market Withdrawal
Recalls
Recalls
Class I Class II Class III
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2 EVALUATE the hazard
3 IDENTIFY product and scope
4 NOTIFY affected parties
5 REMOVE affected product
6
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2
3
4
5
RECALL ACTION PLAN Recall Team
Management
DistributionSales
ProductionPurchasing
Quality Assurance
Recall Coordinator
RECALL ACTION PLAN Support Personnel
Accounting Information Technology
Customer Service Scientific Support
Public Relations Records Management
Legal Regulatory Affairs
7
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Removal of Products from Commerce
Stock Recovery
Market Withdrawal
Recalls
Recalls
Class I Class II Class III
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2 EVALUATE the hazard
3 IDENTIFY product and scope
4 NOTIFY affected parties
5 REMOVE affected product
6
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2
3
4
5
RECALL ACTION PLAN Recall Team
Management
DistributionSales
ProductionPurchasing
Quality Assurance
Recall Coordinator
RECALL ACTION PLAN Support Personnel
Accounting Information Technology
Customer Service Scientific Support
Public Relations Records Management
Legal Regulatory Affairs
7
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
2017
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
2
3
4
5
RECALL ACTION PLAN Recall Team
Management
DistributionSales
ProductionPurchasing
Quality Assurance
Recall Coordinator
RECALL ACTION PLAN Support Personnel
Accounting Information Technology
Customer Service Scientific Support
Public Relations Records Management
Legal Regulatory Affairs
7
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
RECALL ACTION PLAN Essential Plan Elements
1
3
2 EVALUATE the hazard
4
5
ComplaintCondition Evaluation Flow
Chart
Is there a PROBLEM
8
2017
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
RECALL ACTION PLAN
2 Evaluate the hazard
Is it MY problem
RECALL ACTION PLAN Preparation 2 Evaluate the hazard
How is my problem bad
Recalls
How much
information is enough
9
2017
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
RECALL ACTION PLAN Essential Plan Elements
3 IDENTIFY product and scope
1
2
4
5
SOURCE
PRODUCT(S)
LOCATION
REPORTABLE FOOD REGISTRY
httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm
10
2017
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
2017
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4 NOTIFY affected parties
5
Recall Notice
Press Release
11
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
URGENHeader T FOOD RECALL
Firm Contact Information and Date
National RecalSt
l of Naturersquoatement
s Nest of
Brand Recall
YUMMY YUCKIES
ABC Company nc Date TodayCalifornia CA1-800-123-4567
APBC
r Co
Od ofu
Cc
atlifio
ornnia CIn
Af ois rr
emcalling
atio6 ouncn ndash
e cPontr
aoineb
rs le
of Naturersquom ndash S
s Nest top
Brand Sal
Yeum S
myt Yautckie
esrdquom
cerealent
cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the
affected product
illnesses have been Detailed P
reported iroduct
n connect Inf
ion ormat
with thisi product on ndash
and no other NaStatement
turersquo sof Nest products are
by affect
the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co
YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013
request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB
rC Direct
Co will arrange ives
for shipping to our plant in CaliforniaCA
C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have
records regardior
ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely
Request be requested
r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567
STh
tank y
anou
dafo
rr
dyour
S Ccooperat
losi
ron
incerely u e
be s
No ed
Yuc de
We or an o re
AB be c
You ve
Company President
Donrsquot Be THAT Guy
RECALL ACTION PLAN Essential Plan Elements
1
3
2
4
5 REMOVE affected product
12
2017
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
2017
REMOVAL
RECONCILIATION
EFFECTIVENESS
DISPOSITION
TERMINATION
RECALL ACTION PLAN Essential Plan Elements
1 ASSIGN roles and responsibilities
3 IDENTIFY product and scope
2 EVALUATE the hazard
4 NOTIFY affected parties
5 REMOVE affected product
4 Hours
13
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Recall Coordinator Resources
Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you
bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx
bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm
Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution
Requested Documents
Affected Product
Product Information
Labels
Draft Recall Notices
Draft Press Releases
Requested Documents
Amount of Product Made or Received
Amount Distributed
Distribution List
14
2017
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Distribution List
Distribution List
Business Type Customer May Use Product as an
Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products
Mock Recall Exercise
15
2017
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
2017
Resources
Follow CDPH‐FDB on Twitter CDPH_FoodAlert
16
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17
Recovery
Recall Closure
Review of Process
Revision in Process
Reinvention
Remarketing
If You Have Questions Contact
State Government
CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500
California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)
Federal Government
US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)
US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)
Questions
2017
17