619929
Richard Wolf Medical Instruments Corp. — FEI 1418479
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 9, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |