Northwest Eye Design, LLCFebruary 2, 2024

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

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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.

Company: Northwest Eye Design, LLC
Inspection Date: February 2, 2024
Product Type: Device
Office: Division of Human and Animal Food Operations - West VI
Person: Stephen R. Souza

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ID · 848244d9-e8f0-4acf-8732-838ed150aa7d