FDA Inspection 1121063 — Richard Wolf Medical Instruments Corp.
The FDA completed an inspection of Richard Wolf Medical Instruments Corp. on March 18, 2020 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 18, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Vernon Hills, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |