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.
