USFDA completes Pre-Approval Inspection at Dr. Reddy’s Srikakulam formulations manufacturing facility

24 Aug 2024 Evaluate

The United States Food & Drug Administration (USFDA) has completed a product-specific Pre-Approval Inspection (PAI) at Dr. Reddy’s Laboratories’ formulations manufacturing facility (FTO SEZ PU1) in Srikakulam, Andhra Pradesh. The inspection was conducted from August 19, 2024 to August 23, 2024. The company has been issued a form 483 with three 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.


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