543738
Tenex Health, Inc. — FEI 1000135560
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 5, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lake Forest, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4189 | 21 CFR 820.198(a) | General |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |