Biotechnology major Biocon Wednesday said the US health regulator has issued six observations in Form 483 after pre-approval inspection of its insulin drug substance manufacturing facility in Bengaluru. The United States Food and Drug Administration (USFDA) concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application submitted by the company's insulin API customer, a company spokesperson said in a statement.
"The inspection at the Bengaluru facility took place between February 25-March 5, resulting in a Form 483 with six observations," it added.
Biocon is confident of addressing these expeditiously and remains committed to global standards of quality and compliance, the statement added.
The FDA Form 483 is issued to a firm's management at the conclusion of an inspection "when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."