FDA Inspection 1061747 — Artivion, Inc
The FDA completed an inspection of Artivion, Inc on Aug 8, 2018 in Kennesaw, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 8, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kennesaw, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |