FDA GMP Warning Letters Review: Compounding Pharmacies Drew The Most Letters In 2016

More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.

2016 Drug GMP Warning Letters By Facility Type, Day 4

The majority of last year’s 110 drug GMP warning letters, 56, went to compounding pharmacies, including 21 to registered outsourcing facilities.

That’s more than twice the number of warning letters FDA sent pharmacies in fiscal year 2015, but just 51% of...

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