Dr Reddy’s Laboratories has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) following an inspection at its formulations manufacturing facilities, FTO-7 and FTO-9, in Duvvada, Visakhapatnam. The US FDA has classified the inspection as Voluntary Action Indicated (VAI), indicating that while observations were made, no immediate regulatory action is required.
This update follows the company’s disclosure on May 17, 2024, regarding the USFDA inspection. The inspection is now classified as “closed” under 21 CFR 20.64(d)(3).