Inspect your FDA Inspector Before Your Inspection

Today, I’m excited to officially announce a new set of services to help you prepare for your next FDA inspections – FDA Inspector Profiles.

We’ve taken 16+ years of FDA inspection data and combined it with other relevant databases to bring you a comprehensive, detailed look into any individual FDA Inspector.

Each investigator brings their unique perspective, experience and idiosyncrasies, the study of which is demonstrated to be a crucial element of inspection management, readiness, and preparation. With the Inspector Profile, you’ll be able to see the inspector’s:

  • 483 issue rate
  • Total inspections
  • Total 483s
  • Most common citations (based on CFR), CFR description, and citation frequency
  • Longest / shortest inspection in duration – all time, last year
  • Total warning letters

Here’s an example from the infamous Peter Baker:

FDA Inspector Peter Baker, FDA Investigator

 

You’ll also get the inspector’s entire inspection history, including inspection details for every inspection since 2000, including:  company, site inspected, duration of inspection, Co-inspectors, year of last co-inspection, number of co-inspections, if a 483 issued, and whether or not it resulted in a warning letter (in .csv format)

HOW TO GET INSPECTOR PROFILES

Individual Inspector Profiles – $995 $795

Inspector Profiles allow you to get the strategic view of an inspector, but many also purchase 483s and other inspection documents to get the in-depth view. Every time you purchase an Inspector Profile, you can purchase 483s, 483 responses, and EIRs from our store of 10,000+ inspection documents at a 15% discount for 72 hours.

We’ve also noticed that many of our customers are responsible for multiple sites and anticipate preparing for several inspections over a year. If that’s you, you have two options:

INSPECTOR PROFILE PLANS

And if you are looking to become more proactive in the study of FDA trends as a whole or want better inspection data on your competitors, collaborators, and partners, check out Enforcement Analytics.

Any questions? Feel free to reach out to us at [email protected]

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