FDA Cites Mfg Issues in Biocon’s Insulins Facilities in Malaysia
The US Food and Drug Administration (FDA) has issued a Form 483 to Biocon’s insulin glargine manufacturing facilities in Malaysia following a pre-approval inspection conducted by the agency between June 24 and July 5, 2019. The inspection covered Biocon’s insulin glargine drug-substance, drug-product and device-assembly facilities and concluded with 12 observations issued on a Form 483.
A Form 483 by the FDA is issued to a firm at the conclusion of an inspection to notify the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are then encouraged to respond to the Form 483 in writing with their corrective action plan and then to implement that action plan expeditiously, according to information from the agency.
Biocon says it will respond to the FDA with a corrective and preventive action plan and that it does not expect any change to its commercialization plans for insulin glargine in the US, according to a company filing with the Bombay Stock Exchange.