FDA Inspection 1074008 — Sunset Healthcare Solutions Central Warehouse
The FDA completed an inspection of Sunset Healthcare Solutions Central Warehouse on Oct 12, 2018 in Elgin, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 12, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elgin, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3837 | 21 CFR 820.25(b) | Training records |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |