Biocon has received 6 observations from the US health regulator, after it had inspected its Malaysia manufacturing facility.
The company in a regulatory filing stated, “The USFDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with six observations. As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner.”
The Form 483 is issued, when the investigator feels that conditions or practices in the facility are such that, the products are adulterated or harmful to health. Further, the company did not share the details of the observations made by USFDA.