Dr Reddy's Labs gets USFDA EIR for Middleburg facility
Mumbai: Pharma major, Dr Reddy's Labs, has recently announced that the company has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), for its Active Pharmaceutical Ingredient (API) manufacturing plant at Middleburg, New York, indicating closure of the audit and the inspection classification of this facility is determined as 'Voluntary action indicated' (VAI).
Voluntary Action Indicated (VAI) means objectionable conditions or practices that were found but the agency is not prepared to take or recommend any administrative or regulatory action.
"Further to our intimation dated March 10, 2021 with regard to the audit of our API manufacturing plant at Middleburg, New York, we would like to inform you that we have received the Establishment Inspection Report (EIR) from US FDA, for the above-referred facility, indicating closure of the audit and the inspection classification of this facility is determined as 'Voluntary action indicated' (VAI)," the company said in a BSE filing.
According to USFDA, EIR means closure of inspection. After the inspection conducted by regulatory body, Establishment Inspection Report (EIR) is prepared by FDA's investigator after the completion of the inspection.
Currently, we do not have any sales from this plant, the company added.
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Dr Reddy's Laboratories had earlier got Form 483 with three observations after the US health regulator inspection had conducted at its manufacturing facility in Middleburg, New York.
Read also: Dr Reddy's Labs Gets USFDA 3 Observations For New York API Facility
Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
Dr. Reddy's operates in markets across the globe. The company's major markets include - USA, India, Russia & CIS countries, and Europe.
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