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

Source: https://www.globalkeysolutions.net/records/483/northwest-eye-design-llc/848244d9-e8f0-4acf-8732-838ed150aa7d

> FDA 483 for Northwest Eye Design, LLC on February 02, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northwest Eye Design, LLC
- Inspection Date: 2024-02-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Documents

- [483 - 2020-01-10](https://www.globalkeysolutions.net/records/483/northwest-eye-design-llc/e4807bbb-b845-4e2c-af08-22d948cc970c)

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/northwest-eye-design-llc/eb08662b-92e1-4cb6-9dbf-f780fbf30a22

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822