FDA Inspection 1048743 — Sleepsafe Beds, LLC
The FDA completed an inspection of Sleepsafe Beds, LLC on Apr 19, 2018 in Bassett, VA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bassett, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |