Biotech major Biocon said on Saturday that the US health regulator issued six observations after inspecting the manufacturing facilities of its Malaysian subsidiary Biocon Sdn Bhd. The US Food and Drug Administration (USFDA) conducted a pre-approval inspection at the company site The Aspart insulin manufacturing plant of Malaysian subsidiary Biocon Sdn Bhd between September 13 and 24, Biocon said in a statement.
“At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations in the facilities of pharmaceutical substances, pharmaceutical products and devices,” he added. A Biocon spokesperson said the company is confident of addressing these observations through procedural improvements and an appropriate Preventive and Corrective Action Plan (CAPA), which will be submitted to the USFDA in a timely manner. “We do not expect the outcome of this inspection to affect our plans to market Aspart insulin in the US Biocon Biologics remains committed to global quality and compliance standards,” added the spokesperson.
According to the U.S. health regulator, an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any condition that, in their judgment, may constitute violations of the FDA Act. Food, Drugs and Cosmetics (FD&C) and related Law.