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Zydus Lifesciences Ltd informed that the company has received an Establishment Inspection Report (EIR) from the US drug regulator, United States Food and Drug Administration (USFDA) for its formulations facility at Moraiya, near Ahmedabad.
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), a Zydus statement said.
The USFDA had inspected the facility from July 26 to August 5, 2022 which concluded with four observations relating to Form 483 observations. None of the observations were relating to the data integrity, the agency had noted then.
On Monday, the USFDA has indicated that the inspection is closed, the statement said.
Moraiya plant located near Ahmedabad manufactures formulations products of the company.
Zydus shares traded positive with gains of 0.65 per cent at ₹442.95 on stock exchanges Monday.
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