874460
WalkMed Technologies, LLC — FEI 3000204189
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 15, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |