FDA Inspection 1165161 — Custom Smiles Sleep Department
The FDA completed an inspection of Custom Smiles Sleep Department on Mar 18, 2022 in Kannapolis, NC. 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). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 18, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kannapolis, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |