FDA Inspection 640723 — Merge Healthcare, Inc.
The FDA completed an inspection of Merge Healthcare, Inc. on January 20, 2010 in Hartland, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hartland, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 749 | 21 CFR 803.52(b)(3) | Date of Event |