New Delhi: Biotechnology major Biocon has announced the US health regulator has completed the inspection of its new manufacturing facility in Bengaluru without any observations. “The United States Food and Drug Administration(USFDA) conducted a pre-approval inspection of our new oral solid dosage forms manufacturing facility at Biocon Park in Bengaluru from November 5-9, 2018,” Biocon said in a regulatory filing.
The audit concluded without any observations and no Form 483 was issued, the company added.
A Form 483, is issued by the USFDA to notify a company’s management of any objectionable conditions at its manufacturing facilities. It is issued to the management of a firm at the conclusion of an inspection.