FDA Inspection 1064057 — XVIVO Perfusion, Inc
The FDA completed an inspection of XVIVO Perfusion, Inc on Aug 30, 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 30, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Englewood, CO (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3003 | 21 CFR 812.140(b)(6) | Other sponsor records required by FDA inadequate |