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FDA audit series part 5, dealing with the 483 or Warning Letter
This document discusses how to respond to an FDA Form 483, which details observations from an FDA inspection. It recommends developing a team to work on the response within the required 15-day timeframe. The response should systematically resolve all observations, include any documentation of changes made, and address how products are acceptable. It also advises having the response reviewed by others and possibly legal counsel. Management should provide a cover letter, and the response should be delivered before the deadline using return receipt to confirm.
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FDA audit series part 5, dealing with the 483 or Warning Letter
- 1. Part 5 –What to do with that 483
- 2. • You askedfor it… Wanted more review of the steps involved • This series is designed in parts • • • • • Part 1 – Preparing for the FDA Part 2 – What to do when the FDA arrives Part 3 – What to do while the FDA is there Part 4 – What to do during closeout Part 5 – What to do with the 483 This is Part 5 – What to do with that 483
- 3. When the auditis over, people typically want to go home…relax….take a vacation…anything but deal with the outcome. You have 15 days to respond (those are working days) You now have to get going on the response • Develop your team • Have a format for the response
- 4. You need peopleto work on the response – and management has to be involved in supporting you • People to assess what needs to be changed • People to write the response work • People to gather the data • Management should have a cover letter to the response
- 5. You have toresolve the observations systemically Include copies of any changes made – SOPs, batch records, etc. Include training copies as necessary Address how the product is acceptable (hopefully it is) – on the market currently, in operations now and how to control it in the future
- 6. As you putthe document together, have it reviewed A new set of eyes may have questions that you didn’t see – working closely to a subject will blind you to some obvious issues Serious issues may warrant some legal review All of these things take time – people have to know the “drop dead” date for the response to be finalized. Delivery – return receipt!!! Copies to all pertinent parties
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