# Artegraft, Inc. – FDA Inspection, Apr 16, 2025

Source: https://www.keypedia.com/records/fda_inspections/artegraft-inc/4ba57aee-568b-4a33-a2e7-c5fb71467292
Source feed: FDA_Inspections

> FDA inspection 1235542 of Artegraft, Inc., April 16, 2025. Classification: Official Action Indicated (OAI). 8 citations under 21 CFR part 820. Form 483 issued. 7 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1235542
- Company Name: Artegraft, Inc.
- Inspection Date: 2025-04-16
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Compliance: Medical Devices
- Product Type: Medical Devices & Rad Health
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 8

## Related Documents

- [FDA Inspection 1325342 - 2026-06-25](https://www.keypedia.com/records/fda_inspections/artegraft-inc/042f5669-93b7-4704-a81e-2afc48e7f814)
- [FDA Inspection 1202728 - 2023-04-13](https://www.keypedia.com/records/fda_inspections/artegraft-inc/fc0624e3-73df-4afa-99ca-5e58fe389339)
- FDA Inspection 1044392 - 2018-02-16
- [FDA Inspection 911848 - 2015-01-28](https://www.keypedia.com/records/fda_inspections/artegraft-inc/acb41225-09ea-4d50-b723-0472b004f196)
- FDA Inspection 816080 - 2013-01-25

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)
- [Company Rep](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)
- [Issuing Officer](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

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

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7