Biocon Gets Four Observations From U.S. FDA For Bengaluru API Facility

Biocon Ltd. on Saturday said the U.S. health regulator has issued four observations after inspecting its Bengaluru-based active pharmaceutical ingredient facility.

The US Food and Drug Administration conducted a surveillance inspection of the API facility (Site 2), located at Bengaluru from September 23- 27, 2024, the company said in a regulatory filing.

'Four observations were cited at the end of the inspection, which the company will be addressing within the stipulated time,' it added.

The company does not foresee any impact on the business, Biocon said.

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