|
California Devicemaker Warned By FDA on Numerous GMP Lapses
An optical supplies manufacturer has received an FDA warning letter for nine violations, most relating to complaint handling, device design and process control procedures. The letter to American Optisurgical (AOI) from the FDA’s Los Angeles District Office is dated June 14 and follows a Jan. 30-Feb. 23 inspection of the company’s Lake Forest, Calif., plant.
Devices & Diagnostics Letter |
|
Register Now
Archives