First-Ever OTC Inspections Drove Surge Of FDA Warning Letters In FY 2019
Executive Summary
The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.
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FDA Warning Letters Hit Small OTC, Large Pharma Firms With Same Citations In FY 2019
Inadequate process controls and faulty failure investigations were the top GMP violations found in warning letters sent in FY 2019 to companies large and small.