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Pharma major, Dr Reddy’s Laboratories, received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad. The US drug regulator has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is “closed”, the Hyderabad-based drug-maker said.
In the third quarter results announced recently, Dr Reddy’s said the US FDA completed its inspections at the company’s Bachupally facility. The responses to the observations were submitted within stipulated timelines.
In the product specific, Pre-Approval Inspection (PAI) at biologics manufacturing facility in October 2023, the company was issued a Form 483 with 9 observations.
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