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 to test finished products

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Manufacturing

More from Compliance