The inspection, conducted between August 26 and September 3, 2025, covered several operational areas, including drug substance manufacturing units, analytical quality control laboratories, microbiology labs, and warehouses.
At the conclusion of the inspection, the U.S. FDA issued a Form 483 with five procedural observations.
According to the company, these observations are not related to data integrity, systemic non-compliance, or quality oversight. Rather, they are procedural in nature and do not raise red flags over the company’s quality systems or compliance practices.
Biocon Biologics confirmed that it will submit a Corrective and Preventive Action (CAPA) plan within the stipulated timeline and is confident in its ability to address all the observations expeditiously.
Importantly, the company stated that it does not anticipate any impact on the supply of its commercial products, alleviating concerns over product disruptions or regulatory escalations.“Biocon Biologics will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline and is confident in its ability to address all observations expeditiously. The company does not anticipate any impact on supply of its commercial products,” the company said in its press release.Biocon also reiterated its commitment to maintaining the highest standards of quality and compliance and assured stakeholders of continued collaboration with global regulatory agencies.
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