FDA Warning Letters Hit Small OTC, Large Pharma Firms With Same Citations In FY 2019

By Joanne S. Eglovitch, Senior Editor Manufacturing, “The Pink Sheet”


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.

Whether they were large, established manufacturers of prescription drugs or small, never-before-inspected over-the-counter drug makers, fiscal year 2019 US Food and Drug Administration warning letters tended to cite them for the same types of good manufacturing practice violations, an FDA official said.

Jeff Meng, director of the investigations branch in the Office of Pharmaceutical Quality Operations’ Division 3 in Detroit, shared some insights on the top 10 GMP violations and the significance of these findings at the FDA/Xavier PharmaLink Conference. The conference, held annually at Xavier University in Cincinnati, OH, occurred in virtual-only mode this year due to COVID-19 safety concerns.

Read the full story here.