FDA Inspection 1195082 — Sleep Joy International LLC
The FDA completed an inspection of Sleep Joy International LLC on January 20, 2023 in Northport, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Northport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |