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:
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
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
- 8 Inspector Profiles + 483 Download Service – $6,900 Buy Now>>
- 12 Inspector Profiles + 483 Download Service – $8,900 Buy Now>>
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]