Dr Reddy's Labs gets EIR from USFDA for Srikakulam facility
Hyderabad: Dr Reddy's Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The USFDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is "closed" under 21 CFR 20.64(d)(3).
Voluntary action indicated (VAI) means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Previously, the facility had been issued four observations following an inspection that took place from May 30, 2024 to June 7, 2024.
Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe
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