FDA 483 - Dr. Reddy's Laboratories, Ltd, Biologics - September 12, 2025

Dr. Reddy's Laboratories, LTD, Biologics, a drug substance and drug product manufacturer in Telangana, India, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality unit oversight of environmental monitoring data, poor document control practices, and critical failures in aseptic processing techniques. These issues collectively indicate a lack of robust controls to ensure product quality and sterility.