Biocon receives EIR for its Bommansandra facility

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.

BioconBommansandraEIRpharma inspectionUS FDAVAI
Comments (0)
Add Comment