FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - June 07, 2024

An FDA inspection of Dr. Reddy's Laboratories Limited CTO - Unit VI in Pydibhimavaram, India, revealed significant deficiencies across multiple areas of pharmaceutical manufacturing. The firm failed to adequately validate analytical methods for Active Pharmaceutical Ingredients (APIs) and ensure manufacturing processes remained in a validated state. Furthermore, out-of-specification investigations lacked scientific support and effective corrective actions, and the quality unit released API batches without completing all required tests.