USFDA inspection: Biocon Biologics gets 8 observations for Malaysia insulin facility
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Bengaluru: Biocon Biologics has announced that the U.S. Food and Drug Administration (FDA) conducted two cGMP inspections at Biocon Sdn. Bhd’s Insulins Manufacturing Facility in Malaysia, encompassing Biologics Drug Substance, Drug Product units and Quality Control laboratories, as well as the Delivery Devices unit.
These inspections were conducted between July 10 and July 20, 2023.
At the conclusion of these inspections, the agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories as well as 2 observations for the Delivery Devices unit.
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