803366
Advanced Aesthetic Concepts LP d/b/a/ ProfitSolutions MD — FEI 3006093223
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 16, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3175 | 21 CFR 820.186 | QSR |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |