FDA Inspection 604968 — Sleep Devices, Inc.
The FDA completed an inspection of Sleep Devices, Inc. on Aug 17, 2009 in Kissimmee, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kissimmee, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |