Wednesday, August 29, 2012

#FDA Inspection Readiness: Inspect the Inspector @fdazilla

So get this.  That FDA 483 Store has this uber-awesome feature for inspection readiness:

You can inspect the inspector.

FDAzilla has a page for each of the 772 FDA inspectors involved in their 1,000 Form 483 Reports and cross-referenced two key pieces of information about them:

  1. Which cGMP site they audited
  2. Who else was with them when they conducted the audit
Which means if an FDA investigator shows up in your lobby, you can search their name on the FDAzilla 483 Store and see:

fda 483 investigator inspector

  • See who else they've inspected
  • See who they've worked with
  • Buy and research their 483 observations to see their core expertise
FDA inspectors have core areas of expertise.  Some focus their work in key geographic areas.  The more you know about your inspector, the better you are able to pass the inspection with minimal 483 observations.

This FDAzilla 483 Store is the only tool I know of that lets you inspect the inspector.  

Anyone know of anything better?

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