Learn how others were successful after getting a FDA Warning Letter. For more tips on FDA Warning Letters go to http://compliance-insight.com/fda-483-warning-letters/
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1. Warning Letter Success StoryRe-establishing Your Credibility
with the FDASUCCESSNext Exit
2. What is a Warning Letter? The term warning literally means a
threat orsign of impending danger; so you canunderstand why people
have real concern withregard to the letter from the government
statingWarning. FDA: "...a correspondence that notifiesregulated
industry about violations that FDA hasdocumented during its
inspections orinvestigations. Typically, a Warning Letternotifies a
responsible individual or firm that theAgency considers one or more
products,practices, processes, or other activities to be
inviolation of the Federal Food, Drug, andCosmetic Act (the Act),
its implementingregulations and other federal statutes.
3. When you have a WL
4. Our story beginsCompliance Insight was contacted by a
medical devicemanufacturing company to help with a warning letter
for anumber of significant GMP inspectional observations.
Thefollowing steps were taken to establish regulatorycompliance:
Prepared warning letter response with a time line tocomplete each
observation. Provided periodic status updates to the FDA for the
issuesstated in the warning letter and notification of theremedial
action taken in each case. Trained all the employees on Quality
System Regulations. Established Quality Systems at all levels of
theorganization. Prepared and implemented procedures as per
QualitySystem Regulations. Communicated with the FDA on a continual
basis toensure that all pending issues were
addressedsatisfactorily.
5. What we did to help! We were there to help the company find
theright solutions for their particular needs Trained everyone
Oversight of activities Communicated with the FDA We were part of
the company!!! In the end, the FDA re-inspected the firm andthey
passed with flying colors!!! All issues wereresolved!
6. The Response:Re-establishing CredibilityOnce observations
are given, particularly criticalor major points, the firm has a
limited amount oftime to respond. 15 days!!!Work to put a time
frame around the response inplace and adhere to it diligently.This
is the firms chance to re-establish credibilitywith the FDA.Visit
our website for some tips on how to writethe response, format
recommendations andexamples: www.Compliance-Insight.com
7. An approach for formulating aresponseEvaluate the current
state of compliance in light of theaudit observation. If possible,
indicate what is compliant.Identify the root cause of the issue as
appropriate.Understand how the firm will resolve the issue
systemically.Review prior commitments. Are any issues a
repeatobservation or a repeat observation for the same typesystem
issue? This is critical to know and understand. Ifyou have made a
commitment in the past regarding anobservation but the corrective
actions were notimplemented or did not resolve the issue, the
inspectingbody will evaluate the current observations in a
morecritical light. Repeat observations also greatly increase
thelikelihood of further regulatory actions.
8. When we leftthe firm was compliant!!
9. We have the answers and solutionsCall us at
513-860-3512
10. Questions? More Information?Compliance Insight, Inc.Call us
at513-860-3512Email us
[email protected]