731750
AcquaMed Technologies Inc — FEI 3004691767
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oswego, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 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 |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |