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Compliance In Focus
Posted by John Lehmann on Thu, Dec 15, 2011

Effective Responses to Avoid Warning Letters

Following an FDA inspection and exit interview, the FDA investigator will discuss the findings from an inspection and if deficiencies are found, a FDA 483 Inspectional Observations may be issued. The 483 describes any inspection findings that represent deviations from applicable agreements and regulations. The response to a FDA 483 is crucial. An article published in GxP Perspectives highlights sentence fragments from Warning Letters which seem to indicate a missed opportunity to avoid a Warning Letter following an FDA 483:

“The adequacy of the response cannot be determined because the response did not include…”
“We have reviewed your firm’s response and note that it lacks sufficient corrective actions regarding…”
“Your response does not address…”
“Your response is inadequate because…”

The article further points out that while a response to a 483 is not always mandatory; the FDA is more likely to view a quality response as adequate. What are some guidelines when preparing a response?

  • Establish the true root cause of the observation from the 483 so it can be fixed properly and permanently.
  • Provide specifics regarding any corrective actions taken or proposed.
  • Provide supporting documentation for every claim to re-enforce commitment.
  • Review recent FDA Warning Letters and note responses that were not adequate to ensure mistakes are not repeated.

Whether you are a sponsor, monitor, or site, everyone has a stake in the outcome of an inspection. Being aware of the most common FDA findings and trends is important for any study team member to help prevent repeating the same mistakes. IMARC has two whitepapers currently available under the Resources Tab which detail the Top Ten Warning Letter Findings from 2009 & 2010. Please take time to download our papers.  And, stay tuned for IMARC's upcoming whitepaper for 2011 FDA Warning Letter Findings for Clinical Investigators.

Topics: john lehmann, FDA, Warning Letters

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