Dr. Reddy’s Laboratories Receives USFDA Inspection Report

Dr. Reddy’s Laboratories Limited has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) regarding the inspection conducted at their formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India. The inspection, which took place earlier, has been classified as 'Voluntary Action Indicated (VAI)' and officially closed under 21 CFR 20.64(d)(3). This outcome indicates that while the FDA has identified some issues, they do not require immediate corrective action. The company had previously informed about the Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) conducted by the USFDA. This filing serves as an official intimation of the inspection outcome to the National Stock Exchange of India Ltd., BSE Limited, New York Stock Exchange Inc., and NSE IFSC Ltd.