FDA Inspection 863605 — ASD Sleep, LLC
The FDA completed an inspection of ASD Sleep, LLC on January 24, 2014 in Cedar City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 24, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cedar City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |