FDA Inspection
Artegraft, Inc.Artegraft, Inc. – FDA Inspection, Apr 13, 2023
Record Details
This FDA Inspection record concerns Artegraft, Inc., with an inspection on April 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fc0624e3-73df-4afa-99ca-5e58fe389339
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202728
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Artegraft, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2026 | Not classified | New Jersey District Office | Compliance: Devices |
| April 16, 2025 | OAI | Center for Devices and Radiological Health | Compliance: Medical Devices |
| February 16, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 28, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Artegraft, Inc.
- FDA Inspection 1325342 - 2026-06-25
- FDA Inspection 1235542 - 2025-04-16
- FDA Inspection 1044392 - 2018-02-16
- FDA Inspection 911848 - 2015-01-28
- FDA Inspection 816080 - 2013-01-25
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