Sun Pharmaceutical Industries Ltd.

Team of US FDA (Food and Drug Administration) inspectors, which recently conducted a surprise audit on a Gujarat unit of Sun Pharmaceutical Industries, has reportedly submitted Form 483. Submission of Form 483 means the FDA team found certain procedural issues with respect to the plant's running and seeks corrective action but may not imply an immediate import ban.

The FDA team has made 23 observations (four for injectable units, four for oral solid unit and rest for the quality-control lab) at the Halol unit in Gujarat, which accounts for about 25 percent of Sun’s US sales. The US market accounts for 60 percent of the company’s total sales. Though, the FDA did not find any data integrity issues with the plant.

Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.