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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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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.

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