FDA Inspection
Artivion, IncArtivion, Inc – FDA Inspection, May 23, 2013
Record Details
This FDA Inspection record concerns Artivion, Inc, with an inspection on May 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Artivion, Inc
- Inspection Date
- May 23, 2013
- Product Type
- Devices
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ID · d39b687c-c6eb-42b2-b6e3-b88ddbbf453b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833228
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 1040.10(h)(2)(ii)Reproductions of warnings
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 1040.10(h)(1)(vi)50 mm classification warning
- 21 CFR 1003.10(a)FDA not notified of defect or noncompliance
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Artivion, Inc
14| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 22, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 31, 2023 | VAI | Atlanta District Office | |
| January 20, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Artivion, Inc
- FDA Inspection 1337058 - 2026-09-15
- FDA Inspection 1237253 - 2024-03-22
- FDA Inspection 1218273 - 2023-08-29
- FDA Inspection 1201327 - 2023-03-31
- FDA Inspection 1161220 - 2022-01-20
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