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Form 483 to Biocon, Bengaluru facility

Updated: 06 March 2019

USFDA has given 6 observations in Form 483 to Biocon followed by its Bengaluru plant inspection. A New Drug Application for insulin was submitted by the firm to FDA. Approval of which requires pre-inspection audit resulting into these six observations.

However, the company officials are confident that they can address these issues and stay committed with imparting good quality products by adhering global quality and compliance standards. The inspection was done during 25 February to 05 March in their Bengaluru facility.