The United States Food and Drug Administration (USFDA) issued a Form 483 with two observations to Biocon’ Bengaluru API facility.
Biocon said that the observations are procedural in nature.
“At the conclusion of the inspection the agency issued a Form 483, with two observations, which are procedural in nature,” Biocon said in a regulatory filing.
The US drug regulator conducted a post-approval and GMP inspection of Biocon’s small molecules API manufacturing facility in Bengaluru between February 20 and 26, 2020.
The company said that they are confident of addressing it expeditiously and would respond to the drug regulator with a corrective and preventive action plan in a timely manner.
“We remain committed to global standards of quality and compliance,” the company’s spokesperson said in the statement.
Earlier USFDA issued five observations to Biocon’s another facility after the drug regulatory authority conducted a Pre-Approval Inspection (PAI) and GMP inspection of Biocon’s API manufacturing facility in Bengaluru from January 20 to January 24.