7 Strategies for Avoiding cGMP FDA 483s

Over the years, we’ve written quite extensively about avoiding 483s. Here’s a summary of some of the most timeless advice and perspective.

While the technologies change and the areas of FDA emphasis change quite a bit, the basics of inspections don’t change. Here’s 7 basic strategies for avoiding FDA 483s. Like the saying goes, sometimes common sense isn’t so common.

  1. Document, document, and document more
  2. Shore up quality control at release time
  3. Lock down validation controls
  4. Make sure your written procedures are rock-solid — and follow them
  5. Don’t neglect your physical plant
  6. Don’t make the FDA tell you a dozen times
  7. Get serious about employee training

The X factor in avoiding 483s is something that sounds soft and squishy, but is terribly important and requires leadership from you: a healthy company culture.

We dug back into the archives and found these 3 FDA 483-related trends back in 2012. Oddly enough, these trends are still mostly true today.

  1. FDA is planning stiffer penalties
  2. International Inspections are intensifying and on the rise
  3. US Inspections are intensifying (Inspections have been down in 2014. Lots of reasons as to why, here’s 3)

Bonus: 3 tips for inspection day

Some other FDA 483 resources of interest:
Free, searchable FDA Inspections/483s Dashboard, just updated
FDA InspectorRank
FDAzilla Inspection Readiness Toolkit
More FDA 483 Coverage

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

 

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