717774
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 25, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- American Fork, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15970 | 21 CFR 111.120 | Quality control operations - components, packaging, labels |
| 16066 | 21 CFR 111.35(b)(1)(i) | Written procedures - instruments, controls; calibrating |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3837 | 21 CFR 820.25(b) | Training records |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |