USFDA issues Form 483s to three sites of Biocon
U.S. Food and Drug Administration (USFDA) issues Form 483s to three sites of Biocon Biologics at India and Malaysia. USFDA issues 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site.
USFDA conducted three on-site inspections of Biocon Biologics seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia. These inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022.