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ProfessorGAC

(75,637 posts)
1. FDA Inspectors Seldom Do Site Inspection
Fri Jun 10, 2022, 06:47 PM
Jun 2022

There just aren't enough of them & i don't think there ever were.
I've seen them in sites for review of new applications & know they go inspect places that are already on trouble.
But, they generally don't have the time to just pop into an Abbott plant in Michigan if everything is going fine.
Mostly, they rely on companies to self-monitor compliance as a means to keep their"license" to operate.
OSHA has a specific program called VPP which a site earns with one pre-audit.
I think the FDA has a similar program.
Abbott's problems were poor corporate oversight of lazy site management.
They likely saved but a pittance by letting that plant fall into disarray.
I'll assure you the FDA inspectors were there AFTER the recall, but that would have been the same in the 80s & 90s.
The rest of your post, I'm fully on board.

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