Dr Reddy's Laboratories said that U.S. FDA has asked the drugmaker to initiate voluntary action at its Duvvada facility in Andhra Pradesh.
In a Bombay Stock Exchange filing, the drugmaker revealed that its formulations manufacturing plant at Duvvada, Visakhapatnam, was classified as "Voluntary Action Indicated" following a U.S. FDA audit. Per the FDA, Voluntary Action Indicated (VAI) is one of three classifications defined in the inspection classification database. It means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action.
In August of last year, the FDA issued a Form 483 with eight observations following an inspection of the same facility.
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