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How to Respond to an FDA Warning Letter or 483(s)
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Content of a 483 Response
Your 483 response should be a planned corrective action. You are about to show the FDA how your organization intends on correcting the problem. If you have any questions regarding a finding – especially if there appears to be some ambiguity or confusion – it is important to establish contact with the FDA officer who conducted the audit and ask to restate the observation.
Your planned corrective action should have an estimated time of the steps involved in resolving the deficiency – including the time expected for completion.
Finally your response should indicate that you will forward evidence to support the correction (new procedure, training records, etc).
Responding to Warning Letters
If you received a warning letter the first thing is to stay calm - Don't Panic
Rushing in to correct problems without first doing your homework can have disastrous consequences. Sometimes it helps to hire an outside consultant to help address and reply to the warning letter. This removes any of the emotions attached with the impact of having received the warning.
Responding to a warning letter is essentially similar to responding to a 483. There are some more (difficult) steps involved. First, you want to expedite your response. In some cases an expedited response may mean the cessation of product import restrictions or the end of a ban on sales. This alone usually gets an organization moving to correct the deficiencies.
Unlike the response to a 483 in which the Agency may take your word on the corrective action, in many instances a warning is usually followed up by another FDA audit. It is extremely important that you “clean” up your act substantially. You are not going to get sympathy for not correcting deficiencies. Sometimes it helps to go above and beyond what is required – to give the Agency the sensation that your organization is serious about fixing problems.
Conclusion
In conclusion make sure you have a definite plan on the resolution of any FDA observations. If not clear on the finding make sure you have the FDA explain it to you again. Act prudently but promptly to all observations. And finally, give the FDA a sense that your organization is sincere in it’s desire to correct the problem.
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