US FDA issues 4 observations for Biocon Biologics' insulin facility

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, according to the company.

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26 Aug, 2025 12:21

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The United States Food and Drug Administration (US FDA) issued  four observations for Biocon Biologics facility, the pharma company informed stock exchanges on February 29.

The inspection was 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," the company said in a regulatory filing.

The Company will submit a comprehensive Corrective and Preventive Action (CAPA) Plan to the US FDA within the stipulated time and is committed to addressing these observations expeditiously, it added. 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, according to the company.