USFDA inspection: Dr Reddy's Labs gets zero obervations for Bollaram facility, EIR for Srikakulam facility
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has completed a GMP inspection at the Company's API manufacturing facility in Bollaram, Hyderabad (CTO-3).
The inspection was conducted from June 12, 2023 to June 16, 2023. The inspection closed with zero observations.
Read also: Dr Reddys Labs gets one USFDA observation for Hyderabad facility
The Company has also received the Establishment Inspection Report (EIR) from the USFDA for the formulations manufacturing facility in Srikakulam (FTO SEZ PU2). The Agency 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.
Read also: Dr Reddy's Labs gets 4 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 Reddys major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.
