Biocon has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the Pre-Approval and GMP inspection of its Small Molecules API Manufacturing Facility at Biocon Park SEZ, Bommansandra, Bengaluru, conducted between 20 January and 24 January 2020. At the conclusion of the inspection the agency had issued a Form 483, with five observations, which are being addressed by the Company. The EIR has been closed with a VAI classification for the observations.
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