Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru

"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," Biocon spokesperson said in a statement.

New Delhi: Biotechnology major Biocon on Friday 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 Sep 10 to Sep 19, 2019, Biocon said in a filing to the BSE.

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," 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.

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"The Pre-Approval Inspection of our new facilities does not have any impact on our current commercialisation plans from our existing facilities," the statement said.

The company, however, did not provide any details about the observations made by the US regulator.

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