What's the first thing that happens when an FDA inspector shows up in your lobby?
Personally, I don't know since I'm not usually hanging out in the lobby...
But when I was a cGMP citizen and I had to carry around a pager (smart phone these days)... everyone's pager goes off saying that "the FDA has arrived."
The element of surprise evaporates within 5-minutes of an FDA inspector showing up at your doorstep.
A conference room gets prepped to host the inspectors... A "war room" gets prepped as a proving ground for QA to review presenter talking points.
Good RegA departments will have intelligence on the inspectors already. Smaller outfits will do their research right then and there.
And a good website to go to is FDAzilla's InspectorRank pages. For example, when researching the FDA investigator for the Rhode Island bioreactor contamination, Megan Haggerty came up in the 483.
The InspectorRank page has her email, phone number and tells me right off the bat that she's based in Massachusetts, has audited 105 facilities since 2008 and inspects with a diverse group of peers.
Her historical 483 issue rate is 77%, so if Megan shows up at your door... you're probably going to get a 483 (yes, I know, this isn't a univariate problem).
Farther down, you'll see firms inspected in the past year. So for Megan... that's Amgen, AstraZeneca, Biogen, Genzyme, Alexion, Boehringer, Abbot... etc.
These are all the major biologics manufacturers, so if you're a biotech company, chances are... you're not going to be able to snow Megan.
One beef is that this data seems to be refreshed monthly, so it can be a little stale.
And as previously mentioned, you can even go and purchase select 483 documents that the inspector has issued.
If you have armies of Regulatory Affairs and Quality-folk on it, you're probably fine. If you're a small- to medium- sized outfit, this may be a good resource for you.
Disclosure: FDAzilla licenses Zymergi software
Personally, I don't know since I'm not usually hanging out in the lobby...
But when I was a cGMP citizen and I had to carry around a pager (smart phone these days)... everyone's pager goes off saying that "the FDA has arrived."
The element of surprise evaporates within 5-minutes of an FDA inspector showing up at your doorstep.
A conference room gets prepped to host the inspectors... A "war room" gets prepped as a proving ground for QA to review presenter talking points.
Good RegA departments will have intelligence on the inspectors already. Smaller outfits will do their research right then and there.
And a good website to go to is FDAzilla's InspectorRank pages. For example, when researching the FDA investigator for the Rhode Island bioreactor contamination, Megan Haggerty came up in the 483.
The InspectorRank page has her email, phone number and tells me right off the bat that she's based in Massachusetts, has audited 105 facilities since 2008 and inspects with a diverse group of peers.
Her historical 483 issue rate is 77%, so if Megan shows up at your door... you're probably going to get a 483 (yes, I know, this isn't a univariate problem).
Farther down, you'll see firms inspected in the past year. So for Megan... that's Amgen, AstraZeneca, Biogen, Genzyme, Alexion, Boehringer, Abbot... etc.
These are all the major biologics manufacturers, so if you're a biotech company, chances are... you're not going to be able to snow Megan.
One beef is that this data seems to be refreshed monthly, so it can be a little stale.
And as previously mentioned, you can even go and purchase select 483 documents that the inspector has issued.
If you have armies of Regulatory Affairs and Quality-folk on it, you're probably fine. If you're a small- to medium- sized outfit, this may be a good resource for you.
Disclosure: FDAzilla licenses Zymergi software
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