While most firms do a careful study of 483s past and present that may have hit their facility, too few are taking a look at 483s issued to other firms, experts say.
Sometimes you’ll catch up on issues you hadn’t considered, and what’s more, get tipped off as to what the agency is worried about this season. It doesn’t hurt to get a feel for your inspectors, either. Not only has the FDA been showing up more often—and demanding more—the teams it sends are often less experienced than current generations of pharma managers are accustomed to working with. If you can tap your grapevine to see what alarms them, you’re ahead of the game. You can do a bit more recon on your investigator by visiting this free resource from FDAzilla, InspectorRank. You’ll see their “483 issue rate” as well as a list of recent inspections that they have performed. You can also search for 483s available by inspector at the FDAzilla 483s store.
This is especially important given the FDA’s recent inspector hiring binge (600 to 800 have recently come on board). According to one senior QA manager with a large biotech firm, many of the inspectors showing up at his plant are new to the job and years away from having learned their craft.
That being said, even if inspectors seem unreasonable, it’s critical to cultivate a professional relationship—both the company and the FDA inspectors have a job to do. Respect theirs. It’s often a challenge to accommodate new inspectors in training, but they have to learn somehow, so respect that, too. Those relationships always seem to circle back somehow sometime in the future.
Other 483 Resources
- The largest online 483s store (with thousands of FDA 483s in PDF format) Search by inspector or company>>. Readers of this blog receive 20% off – enter “fdazillablog” at checkout.
- The only searchable listing of 483s
- FDAzilla Inspector Rank – how often does your inspector issue 483s?
- FDA 483 article archives