FDA Inspection
Cuattro Imaging LLCCuattro Imaging LLC – FDA Inspection, Feb 15, 2018
Record Details
This FDA Inspection record concerns Cuattro Imaging LLC, with an inspection on February 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e859da1a-a4be-4c1b-bec6-5bf733a553de
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1041558
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Cuattro Imaging LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Cuattro Imaging LLC
- FDA Inspection 754614 - 2011-11-03
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