FDA 483 - Northwest Eye Design, LLC - February 02, 2024

Northwest Eye Design, LLC, a manufacturer of prosthetic eyes in Kirkland, WA, received a Form FDA 483 with two observations. The inspection revealed that the firm failed to evaluate the impact of out-of-tolerance test equipment on device quality, a recurring issue. Additionally, the firm's prosthetic eye labels lacked unique device identifiers (UDI) as required by regulations.