FDA Inspection 605228 — Merge Healthcare, Inc.
The FDA completed an inspection of Merge Healthcare, Inc. on August 12, 2009 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
- August 12, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hartland, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2276 | 21 CFR 820.20(b)(1) | Responsibility, authority and independence |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |