United States Food & Drug Administration (USFDA) has completed a product-specific Pre-Approval Inspection (PAI) and a routine GMP inspection at Dr. Reddy's Laboratories’ formulations manufacturing facility in Srikakulam (FTO SEZ PU2). The inspection was conducted from May 8, 2023 to May 12, 2023. The company has been issued a Form 483 with four observations, which it will address within the stipulated timeline.
Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.
