FDA Inspection 648559 — Midmark Corporation
The FDA completed an inspection of Midmark Corporation on February 24, 2010 in Buffalo Grove, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 24, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buffalo Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |