Biocon Gets USFDA Observations for Bengaluru API Facility
Biocon's Bengaluru-based API facility received four observations from the USFDA following an inspection. The company plans to address the observations within the stipulated time.
Photograph: Kind courtesy Biocon
New Delhi, Sep 28 (PTI) Biocon on Saturday said the US health regulator has issued four observations after inspecting its Bengaluru-based API (active pharmaceutical ingredient) facility.
The US Food and Drug Administration (USFDA) 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.
The US Food and Drug Administration (USFDA) 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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