Biocon Biologics’ Bengaluru Plant Gets Five Observations in US FDA Inspection

5 Sep 2025 , 01:42 PM

Biocon Ltd said on September 4 that the US FDA has completed a routine inspection of its Biocon Biologics facility in Bengaluru. The inspection, held between August 26 and September 3, covered drug substance manufacturing units, quality control labs, microbiology labs and warehouses.

At the end of the review, the FDA issued a Form 483 with five observations. Biocon noted the issues are procedural, not linked to data integrity, systemic non-compliance or quality lapses.

The company said it will file a Corrective and Preventive Action (CAPA) plan within the given timeline and expects to address all points quickly. It added the findings will not affect supplies of its commercial products. In its statement, Biocon said it remains focused on maintaining global quality standards and working with regulators to ensure the safety and reliability of its drugs.

As of 1:37 PM IST, Biocon Ltd shares are trading at ₹361.90. This is a 1.42% gain on September 5, 2025. Biocon Ltd shares have gained 3.13% in the last 5 days, down 2.81% in the last month, gained 11% in the last six months, dipped 5.47% in the last year.

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