Dealing with FDA 483 observations or warning letters
7
FDA 483 Series Part 5 – What to do with that 483
Transcript
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
homerelax.take a vacationanything 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 didnt 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
[email protected] Thanks for watching!