Issue of Form 483 means that the plant has not been approved for production of medicines in its current shape, and must be modified under a ‘corrective and preventive action’ plan.
“The US-FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with 6 observations,” the Indian drug maker said.
“As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner,” it added.
According to the FDA, Form 483 is issued when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
“Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health,” according to the FDA.
The Malaysian plant was built around four years ago and started commercial operations last year.
Biocon Malaysia is the first overseas biopharma manufacturing and research facility of the company and employs nearly 600 people.
The plant makes rh-insulin, and the company plans to make more and more products at the plant.
In December 2016, Biocon Malaysia got a MYR 300 million, three-year contract to supply rh-Insulin cartridges and re-usable insulin pens under the Malaysian government’s Off-Take Agreement (OTA) initiative. The program encourages local manufacturing to reduce the country’s reliance on imports.