New Delhi: Biotechnology major Biocon Monday said the US health regulator has completed the inspection of its Telangana manufacturing facility without making any observations.
“The United States Food and Drug Administration (USFDA) conducted a good manufacturing practice (GMP) inspection of our active pharmaceutical ingredients (APIs) manufacturing facility at Telangana from December 12-14, 2018,” Biocon said in a regulatory filing Monday.
The inspection was 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 condition at its manufacturing facility. The form is issued after completing the inspection.