On conclusion of USFDA's Pre-Approval Inspection and GMP inspection
Biocon announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the API manufacturing facility of the company.At the conclusion of the inspection of the Bengaluru facility, which took place between 20 January and 24 January 2020, the agency issued a Form 483, with five observations.
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