USFDA completes GMP and Pre-Approval Inspection at Dr. Reddy's Andhra Pradesh facility

21 Jul 2025 Evaluate

United States Food & Drug Administration (USFDA) has completed a GMP and a Pre-Approval Inspection (PAI) at Dr. Reddy's Laboratories’ formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India. The inspection was conducted from July 10, 2025 to July 18, 2025. The company has been issued a Form 483 with 7 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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