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Compliance In Focus
Posted by Sandra Maddock on Fri, Apr 5, 2013

What Does FDA Consider When Reading 483 & Warning Letter Responses?

This week is FDA Warning Letter Week at IMARC! Have you had a chance to catch up on theWhat Does FDA Consider When Reading 483  Warning Letter Responses first three blogs that aim to help you response to the FDA? This last blog in the series attempts to take the perspective of the agency when reading your response letters.

You have responded to an FDA Warning Letter or Form 483-now what? IMARC takes the seat of the agent and provides a fictional checklist that could be utilized when reviewing a response to a Form 483 or Warning Letter:

  1. Was the response received on time? Is it well-written and well thought-out?
  2. Who did the response come from? Was this person the most appropriate person to respond?
  3. Did the response note investigation of the cause or systematic errors that resulted in the findings? How were these causes addressed or corrected? Did the response include documentation or objective evidence?
  4. Were the citations understood? Was each citation addressed?
  5. Were corrective action plans well-developed and objective? Are the corrective action plans addressing the systematic errors? Are the corrective action plans developed in a way they can be applied to other areas that may have the same deficiencies?
  6. What is time-frame that the corrective action plans will be assessed for efficiency and effectiveness? How will the corrective action plans be objectively assessed? Are the corrective action plan goals obtainable?
  7. Does the response reflect ownership and acceptance of citations? Does the response reflect understanding of the larger issues and a commitment to compliance with the FDA regulations and dedicated correction to errors noted?

How do you think the FDA is assessing effectiveness of responses to Warning Letters or Form 483s? Who do you think is responsible at the agency for reviewing these responses and following-up the authors or groups that were audited?

Photo Credit: el_rogos

Monitoring as a Mindset



Topics: Form 483, FDA, Warning Letters


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