Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement

Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement

March 6th, 2013 // 11:00 pm @

March 6, 2013

Our recent excellent FDA compliance speaker, Dennis Moore, President, AUK Technical Services, had some great data on the latest FDA compliance trends, including the most common areas where companies are getting 483s.

If you’ve ever dealt with the agency, you know how difficult it can be to extract recent data from them on this subject! Dennis is a former FDAer and he has this ability to get great information from FDA, and then he is good enough to share it with us. He’ll have a lot more of this fascinating FDA compliance data to share in his March 28 Webinar.

According to Moore, the top FDA 483 observations were:

  1. Complaints – big winner
  2. Quality audits
  3. CAPA documentation
  4. Process validation
  5. CAPA procedures
  6. Design validation
  7. Training
  8. Control of Nonconforming product
  9. Management review
  10. CAPA – analyzing processes

Moore also reports that in 2013, we can expect to see a great deal of hard hitting 806 enforcement. FDA is going to force a number of class II recalls that were not voluntarily performed by industry.

Also, beware the $50,000 compliance mistake. You’ll learn about this in the Webinar below, but here’s a hint – You have 15 days to respond to a 483, or else! Miss the deadline, and your FDA 483 response is for naugh

For a lot more interesting and timely compliance data, be sure to check out our upcoming Webinar on this topic – Top Compliance Trends for 483s and Warning Letters, scheduled for March 28.



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