Biotechnology major, Biocon, said it has received a total of eight observations from the US health regulator for its two new biologics manufacturing facilities in Bengaluru.
The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) at two of the company’s new biologics manufacturing facilities in Bengaluru from September 10-19, 2019, Biocon said in a filing to the stock exchange. The inspection included a new drug substance and a drug product unit, it added.
“At the conclusion of the inspection, we received a Form 483 with four observations for the new drug substance facility, three observations for the new drug product facility and one general observation,” a Biocon spokesperson said in a statement. The company is confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously, it added.
The company did not provide any details about the observations made by the US regulator.
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