# FDA 483 - Artegraft, Inc. - June 25, 2026

Source: https://www.keypedia.com/records/483/artegraft-inc/65dab17c-4e28-45eb-9fc2-eba8e27650ea

> FDA 483 for Artegraft, Inc. on June 25, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Artegraft, Inc.
- Inspection Date: 2026-06-25
- Product Type: device
- Office Name: New Jersey District Office
- Summary: The inspection of LeMaitre Vascular, Inc. in North Brunswick, NJ, revealed significant deficiencies in quality system procedures. These issues include inadequate control over production, nonconforming product evaluation, product preservation, and ineffective corrective and preventive actions, as well as design and risk management failures. The findings indicate a lack of robust controls to ensure product quality, safety, and compliance with regulatory requirements.

## Related Documents

- [483 - 2025-04-16](https://www.keypedia.com/records/483/artegraft-inc/81d2d1fa-81af-44ce-bf7b-7db3dd1abcbf)
- [483 - 2025-04-16](https://www.keypedia.com/records/483/artegraft-inc/08edfad1-d279-47a2-b95f-6698d83de16e)
- [483 - 2025-03-04](https://www.keypedia.com/records/483/artegraft-inc/548b7549-00f9-46e6-b25f-fecbd49547e7)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)
- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/artegraft-inc/ea31640f-5897-4972-8d68-16ea7ca1d8eb

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248