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USFDA Issues Form 483 to Biocon’s Bengaluru Unit

Form 483 listing violations in current Good Manufacturing Plant (cGMP) have been issued by USFDA to Biocon following an inspection between May 25 and June 03 2017. USFDA noticed 10 observations in Biocon’s small molecule injectable plant in Bengaluru.

USFDA releases Form 483 if their investigators witness any untoward conditions which in their judgement may constitute violations of the US Food Drug and Cosmetics Act (FD&C) and related laws.

Following are the observations listed by USFDA Form 483:

This inspection was conducted in accordance with the periodic audit requirements for small injectable plant. However, Biocon has responded promptly with a Corrective and Preventive Action Plan (CAPA) and is determined to implement all the observations timely.

USFDA is more stringent with injectable plants and issued Form 483 to same plant with 8 observations earlier this year in April 2017.

Additionally, french regulator “French National Agency for Medicines and Health Products Safety" as part of European Medicine Agency (EMA) reviewed company’s Biosimilar’s Marketing Authorization. The French Agency expressed their concerns over sterile products, biological medicinal products, packaging and quality control testing at the Biocon unit.



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