First-Ever OTC Inspections Drove Surge Of FDA Warning Letters In FY 2019

The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.

Warning Rubber Stamp
FDA Investigators Focused On Uninspected Inventory In FY 2019 • Source: Shutterstock

Worrisome findings as the US Food and Drug Administration finishes visiting never-before-inspected drug manufacturing facilities around the world helped drive a surge in warning letters in the fiscal year that ended 30 September, an agency official said.

These letters went to firms making over-the-counter drug products and targeted inadequate testing of raw materials and components, and failure...

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