FDA 483 - Dr. Reddy's Laboratories, Ltd, Biologics - June 25, 2026

Dr. Reddy's Laboratories Ltd. in Bachupally, India, was cited for severe deficiencies in aseptic processing during drug product and drug substance manufacturing. Observations included inadequate aseptic practices during filling, insufficient environmental monitoring, microbial contamination in intermediates, and a flawed visual inspection program. The firm also failed to adequately review bioburden testing results and provide sufficient training for aseptic operators, indicating a systemic lack of control over sterility assurance.