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First-Time OTC Facility Inspections Drove US FDA Warning Letter Surge In FY 2019

 
• By Joanne S. Eglovitch

The good news: 75% of firms not previously inspected were in compliance with US drug GMP requirements; the bad news, 25% weren't. CDER Office of Manufacturing Quality director Francis Godwin says FDA remains concerned about vulnerabilities in supply chain when OTC firms don't test products for impurities that have harmed and killed consumers in the past.

Worrisome findings from the US Food and Drug Administration's first inspections of drug manufacturing facilities around the world helped drive a surge in warning letters in fiscal year 2019, according to the agency's drug manufacturing quaility director.

These letters went to firms making OTC drugs and targeted inadequate testing of raw materials and components, and failure to...

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