Dr Reddy’s Labs Srikakulam facility gets EIR from USFDA
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 its formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India.
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).
This follows an inspection conducted by the USFDA in July 2025, during which the company received seven observations.
Read also: Dr Reddy’s Labs gets 7 USFDA observations for Srikakulam facility
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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