FDA Inspection
XVIVO Perfusion, IncXVIVO Perfusion, Inc – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns XVIVO Perfusion, Inc, with an inspection on August 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bebcc997-0ecd-4787-a410-418d215c9da9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064057
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of XVIVO Perfusion, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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