Biocon's Malaysian facility completes USFDA inspection

With 6 observations under Form 483

Biocon announced that the U.S. Food and Drug Administration (US-FDA) conducted an on-site preapproval inspection (PAI) of its Malaysian subsidiary Biocon Sdn. Bhd's manufacturing facility for Insulin Aspart between 13 September and 24 September 2021.

At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities.

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