FDA Inspection 900890 — Richard Wolf Medical Instruments Corp.
The FDA completed an inspection of Richard Wolf Medical Instruments Corp. on October 10, 2014 in Vernon Hills, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 10, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 735 | 21 CFR 803.50(b)(3) | Conducting an Investigation |