Dr Reddy's Labs gets USFDA EIR for New York facility
Hyderabad: Dr Reddy's Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for the Good Manufacturing Practice (GMP) inspection at its API facility in Middleburgh, New York.
According to a BSE filing, 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).
Voluntary action indicated means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
The GMP inspection was conducted from 12th May, 2025 to 16th May, 2025 (US EST time). Initially, in May, the company had received two observations from the USFDA, as reported by the Medical Dialogues team.
Read also: Dr Reddy's Labs New York facility gets 2 USFDA observations
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 Reddys major markets include – USA, India, Russia & CIS countries, China, Brazil, and Europe.
Read also: Dr Reddy's Labs gets 7 USFDA observations for Srikakulam facility
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