Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in our database. As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month). Yes it’s true: arguably, the older the warning letter, the less relevant it becomes. However…
Many experts have told us how important it is to follow the arc of a company’s warning letters’ storyline as far back as possible. Is this a systemic issue or a one-off? Has the company improved over time or gotten worse? In our database, you can go back through 17 years of warning letters — that’s twelve more than the FDA unarchived website.
(RELATED: Want to see how you compare to your peers? Get your FREE PEER BENCHMARK ANALYSIS.)
We have also tagged every cGMP-related warning letter to its inspection, tying that data to the specific inspector, site, and any available 483. Armed with the industry’s largest data set of this kind, imagine how quickly you could pull together internal/external benchmarking for a board meeting or a trending report to focus your quality efforts today.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at [email protected].