Biocon Gets 4 USFDA Observations for Andhra Facility
Jun 22, 2024 18:48
Biocon received four observations from the USFDA after an inspection of its API facility in Visakhapatnam, Andhra Pradesh. The company will address the observations within the stipulated time.
Photograph: Kind courtesy Biocon
New Delhi, Jun 22 (PTI) 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.
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