FDA inspectors have stepped up their surveillance of foreign medical device manufacturers, finding that they make up a disproportionate number of process and quality violations that result in formal warning letters.
Foreign firms accounted for about 10% of inspections conducted in 2012 but received 40% of the FDA warning letters. China alone was responsible for 12% of all the quality systems warning letters issued that year.
The most common violations were related to corrective and preventive action procedures, complaint files and quality audits, the FDA said. Regulators noted a significant increase in violations of device history records, which capture manufacturing, distribution, identification and control data.
U.S. regulators really stepped up their game in 2012, saying that they conducted 37% more inspections that year in efforts to close in on poor practices. Foreign inspections in particular increased by 93%.
The FDA also took steps to improve inspection site selection and to ensure that ‘Official Action Indicated’ inspections didn’t end up in the trash pile over missed deadlines or insufficient evidence.
The federal watchdog agency hopes that publishing the data will help regulators watch for emerging issues, help industry keep a closer eye on common problem areas and help firms avoid receiving warning letters, the FDA said.