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FDA audit series part 5, dealing with the 483 or Warning Letter

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Compliance Insight, Inc.
Compliance Insight, Inc.

Dealing with FDA 483 observations or warning letters

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Part 5 – What to do with that 483
• You asked for 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
When the audit is 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
You need people to 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
You have to resolve 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
As you put the 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
Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!

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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 asked for 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 audit is 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 people to 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 to resolve 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 put the 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
  • 7. Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!