FDA Inspection
Artivion, IncArtivion, Inc – FDA Inspection, Oct 16, 2012
Record Details
This FDA Inspection record concerns Artivion, Inc, with an inspection on October 16, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Artivion, Inc
- Inspection Date
- October 16, 2012
- Product Type
- Biologics
View Company Profile
ID · d409705b-1909-44cc-81ae-0dad0fa479eb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 803320
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
12- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(j)Design history file
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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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