FDA Inspection 847720 — GE Medical Systems, LLC
The FDA completed an inspection of GE Medical Systems, LLC on Feb 28, 2014 in Waukesha, WI. 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)
- End Date
- Feb 28, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Waukesha, WI (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |