FDA Inspection
Artivion, IncArtivion, Inc – FDA Inspection, Mar 19, 2014
Record Details
This FDA Inspection record concerns Artivion, Inc, with an inspection on March 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Artivion, Inc
- Inspection Date
- March 19, 2014
- Product Type
- Devices
View Company Profile
ID · e9a1ca0a-2078-48e8-8c20-d367cb7105a7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 870540
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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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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