872655
Tenex Health, Inc. — FEI 1000135560
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 17, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lake Forest, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |