FDA 483 - Patcos Cosmetics (India) Private Limited - July 18, 2025

Patcos Cosmetics (India) Private Limited, an OTC drug manufacturer in Daman, India, was cited for 17 observations during an FDA inspection. Key issues include severe data integrity concerns with altered laboratory records and torn pages, a dysfunctional quality control unit, lack of CGMP training, unvalidated analytical methods and manufacturing processes, and inadequate facility maintenance. Many of these issues were repeat observations from a previous 2023 inspection, indicating systemic and persistent non-compliance with good manufacturing practices.