FDA Inspection 1323782 — Sleep Joy International LLC
The FDA completed an inspection of Sleep Joy International LLC on Jun 24, 2026 in Northport, NY. 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
- Jun 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |
| 23137 | ISO 13485:2016 Clause 7.3.10 | Design and development file does not include or reference required records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |