Biocon has informed that the company has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the Post-Approval and GMP inspection of its Small Molecules API Manufacturing Facility at 20th KM, Biocon Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020. The EIR has been closed with a VAI classification for the observations. At the conclusion of the inspection last month the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the Company.
The above information is a part of company’s filings submitted to BSE.
