Biocon has announced that the US health regulator has completed an inspection of its new manufacturing facility in Bengaluru without any observations. The Biopharmaceutical major said in a regulatory filing, “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.”
The company added that the audit was completed without any observations and no Form 483 was issued. 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.
Biocon also said in a statement released to the stock exchange, “The successful audit of this site reflects our strong commitment to quality and cGMP compliance.”
According to a report, The inspection conducted by USFDA was triggered after Biocon filed for an abbreviated new drug application (ANDA) or product approval in the US, of which the details of the product has not been disclosed yet.