FDA Inspection 1050573 — XVIVO Perfusion, Inc
The FDA completed an inspection of XVIVO Perfusion, Inc on May 3, 2018 in Englewood, CO. 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
- May 3, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3343 | 21 CFR 820.198(e) | Maintained |