1164672
Advance-Esthetic LLC — FEI 3013397886
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 15, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |