Dr Reddy's Labs gets USFDA EIR for Bachupally facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-02-12 07:12 GMT | Update On 2024-03-21 15:35 GMT

Hyderabad: Pharma major 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 formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.The USFDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is "closed" under 21...

Hyderabad: Pharma major 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 formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.

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

Medical Dialogues team had earlier reported that the USFDA had completed an inspection with ten observations at the company's formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.

Read also: Dr Reddy's Labs gets 10 USFDA observations for Bachupally facility

"In furtherance to our intimation dated October 28, 2023, on the inspection conducted by the United States Food & Drug Administration (USFDA) at the Company’s formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad, we wish to inform you that the Company has received the Establishment Inspection Report (EIR). 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)," the Company stated in a BSE filing.

Read also: Add geographically distributed Govt sites: CDSCO Panel tells Dr Reddy's on antirheumatic drug Abatacept study

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offer 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 major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Dr Reddy's Labs gets USFDA EIR for Bachupally facility

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