"Let's not even talk about warning letters. One moderately bad 483 possible costs us - all in - about $250,000 of internal and external resources."
ENFORCEMENT ANALYTICS is the industry's first comprehensive inspection and enforcement database, where you can search and download data on inspectors, sites, warning letters, and inspectors.
"In my decades of experience in the industry, I've never seen anything like this - having a centralized source for inspector and inspection data is extremely valuable."
FDAzilla has developed a semi-automated linking algorithm that enables the pairing of warning letters each week. The inspections database is updated every month with the most recent month's data on global FDA inspections since 2000:
Enforcement Analytics is intuitive, easy to use, and meant to be “plug and play.”
With Enforcement Analytics, you get unlimited access to Inspector Profiles. Within seconds, you can find your favorite inspector, her inspection key metrics, her entire inspection history, and even some real-time data on where she might be going next.
Armed with this full inspection history and profile, your team will be better able to prepare for your upcoming inspection and minimize the cost of any ensuing 483s or enforcement action.
You can also get metrics and the full inspection history for any site.
Some of these answers have multi-million dollar consequences.
See available plans that include Enforcement Analytics