U.S. FDA Issues Form 483 With 5 Observations To Biocon’s Bengaluru Facility
An employee in protective clothing works inside a deep freezer area of the research and development center at the Biocon Ltd. campus in Bengaluru, India. (Photographer: Dhiraj Singh/Bloomberg)

U.S. FDA Issues Form 483 With 5 Observations To Biocon’s Bengaluru Facility

Bookmark

Biocon Ltd. on Monday said the U.S. health regulator conducted a pre-approval inspection and good manufacturing practice examination of the API manufacturing facility and has issued a Form 483, with five observations.

As per the U.S.FDA, Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.

"The U.S. Food and Drug Administration conducted a Pre-Approval Inspection and GMP inspection of the Active Pharmaceutical Ingredients manufacturing facility of Biocon Ltd," the biotechnology major said in a filing to BSE.

At the conclusion of the inspection of the Bengaluru facility, which took place between Jan. 20-24, 2020, the agency issued a Form 483, with five observations, the filing said.

"We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously. We remain committed to global standards of quality and compliance," according to company's spokesperson.

Also read: True North Buys 2.44% Stake In Biocon Biologics At $3 Billion Valuation

The shares of Biocon were trading at Rs 292.95 a piece on BSE, down 0.51 percent from the previous close.

BQ Install

Bloomberg Quint

Add BloombergQuint App to Home screen.