FDA Inspection 803320 — Artivion, Inc
The FDA completed an inspection of Artivion, Inc on Oct 16, 2012 in Kennesaw, GA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 13 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 16, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Kennesaw, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |