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

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.