Company
United StatesXVIVO Perfusion, Inc, Englewood, CO – FDA Inspections
Inspection records and compliance data for XVIVO Perfusion, Inc in Englewood, Colorado. 2 FDA inspections on record, 2 Form 483s, last inspected August 30, 2018.
Company Profile
This profile covers XVIVO Perfusion, Inc based in Englewood, Colorado, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected May 3, 2018. Last inspected August 30, 2018.
Most cited issue areas
- DHR documentation of label release {see also 820.184}1 inspection
- Documentation1 inspection
- Maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 30, 2018 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1064057 |
| May 3, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1050573 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
XVIVO Perfusion, Inc
FEI Number
3009736925
Address
3666 S Inca St, Englewood, Colorado 80110, United States
Country
United States
ID: e5ca5b11-19c3-4b32-8f25-1aeccd82aaa9