Company Statement on rh-Insulin for Veterinary use

  • Posted by: Biocon Biologics




Bengaluru, Karnataka, India, February 29, 2024

“The U.S. Food and Drug Administration (FDA) conducted an inspection at Biocon Biologics Limited’s Biocon Campus (Site 1) facility between February 20-28, 2024.

This inspection pertains exclusively to the rh-Insulin (rhI) Drug Substance (DS) supply to a customer for veterinary use. The trigger for this inspection was a Pre-Approval Supplement (PAS) filed by our customer late last year.

 At the conclusion of this inspection, the agency has issued Form 483s with 4 observations. The Company will submit a comprehensive Corrective and Preventive Action (CAPA) Plan to the U.S. FDA within the stipulated time and is committed to addressing these observations expeditiously.

The outcome of this inspection at Site 1 does not impact the manufacturing and distribution of the Company’s commercial products in the US market.

Biocon Biologics remains committed to global standards of Quality and Compliance.”

 – Company Spokesperson



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Author: Biocon Biologics
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