FDA Inspection
XVIVO Perfusion, IncXVIVO Perfusion, Inc – FDA Inspection, May 3, 2018
Record Details
This FDA Inspection record concerns XVIVO Perfusion, Inc, with an inspection on May 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 67130f52-d7fa-4cc3-9cda-51d1567e4f14
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1050573
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of XVIVO Perfusion, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
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