FDA Inspection
United Service Solutions, LLCUnited Service Solutions, LLC – FDA Inspection, Nov 21, 2017
Record Details
This FDA Inspection record concerns United Service Solutions, LLC, with an inspection on November 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 629a9b10-9e3e-412c-a8a4-fa6fd58f7f41
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1031799
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.186QSR
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 11 citations.
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Other FDA inspections of United Service Solutions, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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