Biocon Receives 5 USFDA Observations at Bengaluru Biosimilars Site
New Delhi: Biocon Limited has announced that the United States Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at its biosimilars manufacturing site located at Biocon Park, Bengaluru with 5 observations.
The inspection was conducted between April 20 and April 29, 2026, covering three biologics manufacturing units, five quality testing laboratories, and two warehouses, with the regulator issuing five procedural observations in Form 483 and no repeat observations reported.
The company stated that the observations issued at the end of the inspection are procedural in nature and are not related to data integrity or quality oversight. Biocon further confirmed that it will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline to address the observations raised by the USFDA.
The company expressed confidence that all the observations will be resolved fully and in a timely manner, highlighting its readiness to comply with regulatory expectations.
The inspection forms part of the regulatory review process for biosimilars, evaluating manufacturing facilities, quality systems, and operational readiness for product approvals.
Biocon reiterated its commitment to maintaining the highest standards of quality and compliance across its manufacturing operations while continuing to work closely with global regulatory authorities to ensure the safety, efficacy, and reliability of its products.
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