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Biocon gets two observations from USFDA for Bengaluru-based API plant

Biocon gets two observations from USFDA for Bengaluru-based API plant
New Delhi, Feb 27 () Biotechnology major Biocon on Thursday said the US health regulator has issued a Form 483 with two observations after inspecting its Bengaluru-based active pharmaceutical ingredients (API) facility.

The US Food and Drug Administration (USFDA) had conducted a post approval and GMP inspection of company's small molecules API manufacturing facility at Biocon campus in Bengaluru from February 20 to February 26, 2020, a Biocon Ltd Spokesperson said in a regulatory filing.

"At the conclusion of the inspection the agency issued a Form 483, with two observations, which are procedural in nature," it added.

The company is confident of addressing these observations expeditiously and will respond to the FDA with a corrective and preventive action plan (CAPA) in a timely manner, the spokesperson said.

The US health regulator issues observations by means of a FDA Form 483 notifying the company's management of objectionable conditions at the facility inspected.

Biocon shares on Thurday ended 0.17 per cent up at Rs 299.20 apiece on the BSE. MSS SHWSHW

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