As per the USFDA, a Form 483 is issued to Biocon’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts. At the conclusion of the inspection of the Bengaluru facility, USFDA issued a Form 483, with 5 observations.
USFDA issues Form 483 with 5 observations to Biocon’s Bengaluru facility
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