FDA Inspection 619929 — Richard Wolf Medical Instruments Corp.
The FDA completed an inspection of Richard Wolf Medical Instruments Corp. on October 9, 2009 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). 10 citations were issued during this inspection. Product area: Devices.
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 |