The company has received the EIR from the US Food and Drug Administration (USFDA) for the pre-approval and good manufacturing practice inspection of its small molecules active pharmaceutical ingredient (API) manufacturing facility at Biocon Park SEZ, Bengaluru, it said in a filing to BSE.
Biotechnology major Biocon on Friday said it has received the establishment inspection report (EIR) from the US health regulator for its facility at Bengaluru.
The company has received the EIR from the US Food and Drug Administration (USFDA) for the pre-approval and good manufacturing practice inspection of its small molecules active pharmaceutical ingredient (API) manufacturing facility at Biocon Park SEZ, Bengaluru, it said in a filing to BSE.
The inspection of the plant was conducted between January 20 and January 24, 2020, it added.
"At the conclusion of the inspection the agency had issued a Form 483, with five observations, which are being addressed by the company," Biocon said.
The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, it added.
As per the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
"We remain committed to global standards of quality and compliance," a company spokesperson said.
Shares of Biocon were trading at Rs 357.65 per scrip on BSE, up 2.29 percent from their previous close.Special Offer: Subscribe to Moneycontrol PRO’s annual plan for ₹1/- per day for the first year and claim exclusive benefits worth ₹20,000. Coupon code: PRO365
