FDA Inspection 833228 — Artivion, Inc
The FDA completed an inspection of Artivion, Inc on May 23, 2013 in Kennesaw, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kennesaw, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |
| 5202 | 21 CFR 1040.10(h)(1)(vi) | 50 mm classification warning |
| 5670 | 21 CFR 1040.10(h)(2)(ii) | Reproductions of warnings |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |