713468
Biomed MedEquip Inc — FEI 3002253377
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 4, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rowlett, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |