# FDA 483 - Hansen Ophthalmic Development Lab Inc - April 11, 2025

Source: https://www.keypedia.com/records/483/hansen-ophthalmic-development-lab-inc/50fed96b-2a97-4d27-af72-f733a292262b

> FDA 483 for Hansen Ophthalmic Development Lab Inc on April 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hansen Ophthalmic Development Lab Inc
- Inspection Date: 2025-04-11
- Product Type: device
- Office Name: Seattle District Office
- Summary: Hansen Ophthalmic Development Laboratory Inc. in Bellingham, WA, a manufacturer of Class II medical devices, was inspected and received a Form FDA-483 with ten observations. The inspection revealed severe deficiencies across its quality system, including a lack of established procedures for medical device reporting, design control, CAPA, complaint handling, purchasing controls, quality audits, and document control. The firm also failed to establish a design history file, adequately maintain device history records, and ensure UDI labeling requirements were met for its medical devices.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/hansen-ophthalmic-development-lab-inc/ef18025a-da7a-4ea2-9b84-28b6b3b731a4

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913