483
Northwest Eye Design, LLCNorthwest Eye Design, LLC – FDA 483, Feb 2, 2024
Record Details
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.
View Company Profile
ID · 848244d9-e8f0-4acf-8732-838ed150aa7d
Other documents for Northwest Eye Design, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.