USFDA issues six observations after inspection of Biocon's Malaysian arm manufacturing facility

Biotechnology major Biocon on Saturday said the US health regulator has issued six observations after the inspection of the manufacturing facility of its Malaysian subsidiary Biocon Sdn Bhd. The US Food and Drug Administration (USFDA) conducted an on-site pre-approval inspection of the company's Malaysian subsidiary Biocon Sdn Bhd's manufacturing facility for Insulin Aspart between September 13 and September 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 across Drug Substance, Drug Product and Devices Facilities," it added.

A Biocon spokesperson said the company is confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the USFDA in the stipulated time.


"We do not expect the outcome of this inspection to impact our commercialisation plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of quality and compliance," the spokesperson added.

As per the US health regulator, an FDA Form 483 is issued to firm 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 Act.