Biocon's API Plant Gets 2 FDA Observations After Inspection

Biocon Ltd. informed that its Active Pharmaceutical Ingredient (API) manufacturing facility in Visakhapatnam, Andhra Pradesh, has received two observations from the United States Food and Drug Administration (US FDA) consequent to a routine inspection.

It the biopharmaceutical company’s local regulatory filing, the medical regulator in the United States conducted a GMP surveillance inspection at the manufacturing site from November 3 to November 7, 2025. The inspection was completed with the issuance of two observations recorded in Form 483. Form 483 usually indicates that the points raised in the conversations or documentation require corrective actions.

Biocon pointed out that the observed issues are not anticipated to significantly affect the company's business activities. The organization pledged that it is taking necessary measures to resolve the issues referred to by the US FDA within the given period.

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"The company continues to be very much alive to the need to uphold the quality and compliance standards at its various manufacturing units," Biocon stated in its report.

Biocon's factory in Visakhapatnam is a significant contributor to the company's global API supply chain, which serves both regulated and emerging markets. The company is subject to regular inspections by regional and international regulatory authorities as part of its ongoing compliance framework, which ensures adherence to global quality standards.

This news is consistent with the narrative of Biocon staying the course towards manufacturing excellence and regulatory alignment, thus solidifying its status as a major player in the biopharmaceutical industry globally.