FDA Inspection
Sunset Healthcare Solutions Central WarehouseSunset Healthcare Solutions Central Warehouse – FDA Inspection, Oct 12, 2018
Record Details
This FDA Inspection record concerns Sunset Healthcare Solutions Central Warehouse, with an inspection on October 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 12, 2018
- Product Type
- Devices
- Person
- Emma R. Schaefer (Issuing Officer)
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ID · 9b0009cb-148e-4f2c-b0e9-297c961b9401
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074008
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
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