USFDA issues Form 483 for 3 observations to Biocon for Telangana plant

"Three observations were cited at the end of the inspection, which we will be addressing within the stipulated time," it added.

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USFDA Form 483
USFDA Form 483

Last Updated on October 9, 2024 by The Health Master

Biotech major Biocon has received three observations from the United States Food and Drug Administration (USFDA) after the global regulatory authority inspected its Telangana-based manufacturing plant.

The US Food and Drug Administration concluded a pre-approval inspection for Site 3 located at Hyderabad on July 20, Biocon Ltd said in a regulatory filing on the bourses.

“Three observations were cited at the end of the inspection, which we will be addressing within the stipulated time,” it added.

The company stands committed to the quality, safety, and efficacy of its products stated Biocon.

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