FDA Regulatory Update Seafood Products Association Processors Workshop March 4, 2014 Miriam Burbach Compliance Director Seattle District Office, U.S. FDA
FDA Regulatory Update
Seafood Products Association
Processors Workshop
March 4, 2014
Miriam Burbach
Compliance Director
Seattle District Office, U.S. FDA
• Top Ten Deficiencies
• Environmental Samples
• Warning Letters
• Imported Seafood
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21 CFR123.11(b)
21 CFR123.6(b)
21 CFR123.11(c)
21 CFR123.6(b)
21 CFR123.6(c)(4)
21 CFR123.6(c)(1)
21 CFR123.6(c)(2)
21 CFR123.6(c)(3)
21 CFR123.6(c)(5)
21 CFR123.6(d)
Nationwide 1666 1177 833 846 851 816 792 819 777 618
Seattle 215 94 79 65 45 61 82 50 40 45
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Seattle District Comparison of Top 10 Nationwide Deviations
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Importers
Avoid Delays and Extra Costs
• Check the Import Alerts lists prior to
importing products – http://www.accessdata.fda.gov/cms_ia/industry_16.ht
ml
• There are nearly 50 import alerts that do
or may pertain to seafood
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Import Alerts
• Is your regular supplier on import alert but your private lab testing has been finding no problems?
• Refer to the text of the particular import alert for specific guidance on how to get the manufacturer off the List
• Also refer to Chapter 9.6 of the Regulatory Procedures Manual
• You are allowed to submit the petition on behalf of your foreign supplier, or they can submit it.
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Petitions for Import Alerts
• Petitions - detailed and well-thought out
cover letter with supporting evidence (e.g.
past good lab reports); some may
necessitate more, such as HACCP
verification
• How-to questions and petition submissions
do not go through the local FDA office, but
rather Division of Import Operations (DIO):
– DIO 301-796-0356
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Imported Seafood
• Additional time-and money-saving tips regarding imported seafood: – Make sure the filer enters the correct foreign
manufacturer. Does it match with the paper entry documents and invoice? Mis-matches will result in your product being stopped.
– Importing returned US Goods? Have filer note “USGR” in description line and provide documentation from foreign country or entity showing reason for their refusal and return. Back-tracking on this can turn into more time and effort than noting it up front.
– Direct exports and returns by truck to Canada: save yourself CBP (Customs) fines by having the trucker stop to have the export paperwork signed off as they cross the border.
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Importer HACCP Verification
• Importer HACCP Verification of your foreign suppliers – Requirement under 21 CFR 123.12
• If your product is not obtained from a country that has an active MOU for inspectional compliance, then you will need to:
• Implement and keep on file written verification procedures; these are checked during a FDA/State domestic inspection of your facility
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Importer HACCP Verification
• HACCP Guarantee Letter from your supplier. [This is only under choice D, as mentioned below.]
• Your specifications for a safe product.
– What safety standards do you expect in the product they supply to you?
– This is based on the hazards associated with the product/process; e.g. acceptable microbial load, acceptable %WPS content, acceptable Aw, et cetera.
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• Documentation of your chosen Affirmative
Step (there are six choices, A through F,
under 21 CFR 123.12(a)(2)(ii))
– Most firms select Choice D. This would
include obtaining a HACCP Guarantee
Letter from your supplier, and a copy of
their HACCP plan.
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Importer HACCP Verification
• Optional: – Your firm’s statement of what you are doing to address 21
CFR 123.12, such as what Affirmative Step you have chosen
• Remember that your supplier is required to review and update their HACCP plans at least annually
• If your Affirmative Step is to get their HACCP plans, make sure the documentation they send you is current
• Importer responsibilities – Review the HACCP plans your supplier gives you, and
dialogue with them to make any needed corrections
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Importer HACCP Verification
• Additional Reference:
• http://www.fda.gov/InternationalPrograms/
Agreements/MemorandaofUnderstanding/
default.htm
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