Dr. Reddy's Laboratories gets EIR for Andhra Pradesh’s manufacturing facility
USFDA has classified the inspection outcome as Voluntary Action Indicated
Dr. Reddy's Laboratories has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its formulations manufacturing facility (FTO-SEZ PU01) in Srikakulam, Andhra Pradesh. The USFDA has classified the inspection outcome as Voluntary Action Indicated (VAI) and concluded that the inspection is officially closed under 21 CFR 20.64(d)(3).
Earlier, the USFDA had conducted GMP and a Pre-Approval Inspection (PAI) at the said facility from December 4 to December 12, 2025, and issued a Form 483 with 5 observations.
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.
