Biocon arm gets multiple USFDA observations across India, Malaysia
Biocon said the inspections were on account of three pre-approval inspections for biosimilar Bevacizumab, rh-Insulin and Insulin Aspart and a capacity expansion inspection for biosimilar Trastuzumab.
New Delhi: Biocon Ltd on Wednesday said the US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia, following inspection of seven manufacturing facilities of its arm Biocon Biologics. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection...
New Delhi: Biocon Ltd on Wednesday said the US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia, following inspection of seven manufacturing facilities of its arm Biocon Biologics. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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