News reports indicate that the government shutdown is over. "Non-essential" federal employees that were furloughed included FDA inspectors (euphemistically called, "Consumer Safety Officers").
Apparently, even the government admits that FDA inspections are... non-essential.
Regardless, I'm quite certain that the effect on the GMP operations around the world was that of pure joy. Inspection Readiness Teams could relax a bit. Regulatory Affairs and QA managers didn't have to be on high alert (especially ones that hadn't been inspected in a while).
FDAzilla reports a significant drop in sales of 483 documents as RegA and Quality managers had no reason for last-minute research on the inspector that didn't show up (but will still collect backpay).
But now that paid vacation the furlough for FDA inspectors is over, it's time for the GMP community to get back on their toes and maintain inspection readiness.
Good luck.
Apparently, even the government admits that FDA inspections are... non-essential.
Regardless, I'm quite certain that the effect on the GMP operations around the world was that of pure joy. Inspection Readiness Teams could relax a bit. Regulatory Affairs and QA managers didn't have to be on high alert (especially ones that hadn't been inspected in a while).
FDAzilla reports a significant drop in sales of 483 documents as RegA and Quality managers had no reason for last-minute research on the inspector that didn't show up (but will still collect backpay).
Good luck.
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