The inspection was carried out from January 20-24, 2020
Biocon has received an Establishment Inspection Report (EIR) from the US 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.
The inspection was carried out from January 20-24, 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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