Company
United StatesCuattro Imaging LLC, Avon, CO – FDA Inspections
Inspection records and compliance data for Cuattro Imaging LLC in Avon, Colorado. 2 FDA inspections on record, 1 Form 483, last inspected February 15, 2018.
Company Profile
This profile covers Cuattro Imaging LLC based in Avon, Colorado, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 3, 2011. Last inspected February 15, 2018.
Most cited issue areas
- Design history file1 inspection
- Design validation - simulated testing1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2018 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1041558 |
| November 3, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 754614 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cuattro Imaging LLC
FEI Number
3008364043
Address
910 Nottingham Rd Apt N11, Avon, Colorado 81620, United States
Country
United States
ID: 4218fa85-c31e-4a5b-8044-5043e9f1036d