FDA Inspection
Sunset Healthcare Solutions LLCSunset Healthcare Solutions LLC – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns Sunset Healthcare Solutions LLC, with an inspection on November 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Emma R. Schaefer (Issuing Officer)
- Todd Q. Dang (Issuing Officer)
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ID · ef0e1c2d-c6dd-4962-b670-dd6e569a5508
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031596
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Sunset Healthcare Solutions LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 8, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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