FDA Hands Out 15 Warning Letters to Devicemakers for GMP Violations

The FDA has posted 15 new warning letters to device manufacturers for GMP violations: 14 to foreign manufacturers and one to a U.S. company.

The UK took the lion’s share of letters, raking in five, with China getting three letters, followed by Germany with two. Italy, France, Argentina and the Philippines also received one warning letter each.

The companies ranged from manufacturers of orthopedic implants, surgical cutting devices, carbon monoxide monitors and contact lenses to makers of menstrual cups and teeth whitening devices.

The FDA noted that it would refuse entry to 10 of the companies’ products until the required corrections were made, and it would not be approving PMAs for Class III devices for 11 of the companies that received warning letters.