Biocon Biologics gets eight observations from USFDA for Malaysia insulin facility

Biocon Biologics on Friday said it was issued eight observations by the USFDA for its insulin manufacturing facility in Malaysia.

The regulatory agency carried out inspection between July 10 and July 20, following which it has issued a Form 483 listing violations.

The US drug regulator issued 6 observations for drug substance, drug product units and quality Control laboratories and 2 observations for the delivery devices unit of Biocon Sdn Bhd, Malaysia, a subsidiary of Biocon Biologics.


"These observations primarily relate to enhancing operational procedures and strengthening training programs," the company said in a statement to stock exchanges.

"The inspections did not identify any data integrity breaches or systemic non-compliance," the statement added.

Biocon Biologics said it will submit a corrective and preventive action (CAPA) plan to the USFDA in a timely manner and are confident of addressing these observations expeditiously.