NEW DELHI: 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.