Biocon gets 4 observations from USFDA for Andhra Pradesh facility

Biotechnology player Biocon on Saturday said the US health regulator has issued four observations after inspecting its manufacturing plant in Andhra Pradesh.

The US Food and Drug Administration (USFDA) concluded a GMP inspection of the company's API facility (Site 5), located at Visakhapatnam, Andhra Pradesh, on June 21, 2024, the company said in a regulatory filing.

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

As per the USFDA, a Form 483 (with observations) is issued to a firm's management at the conclusion of an inspection, when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act.