FDA 483 - Northwest Eye Design, LLC - January 10, 2020

Northwest Eye Design, LLC, a manufacturer of ocular prostheses in Kirkland, WA, received a Form FDA-483 with seven observations during an inspection from January 6-10, 2020. The observations primarily concern deficiencies in quality system procedures, including inadequate CAPA implementation, insufficient documentation for device records (DHR, DMR), undocumented equipment calibration, and poorly defined procedures for incoming product acceptance and document change control. These issues indicate significant gaps in the firm's quality management system.