FDA Inspection
Sunset Healthcare Solutions LLCSunset Healthcare Solutions LLC – FDA Inspection, Nov 8, 2011
Record Details
This FDA Inspection record concerns Sunset Healthcare Solutions LLC, with an inspection on November 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 8, 2011
- Product Type
- Devices
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ID · e0b14bbd-1720-4dc3-a80d-86774f06d0e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753564
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Sunset Healthcare Solutions LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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