FDA Inspection 705630 — GE Medical Systems, LLC
The FDA completed an inspection of GE Medical Systems, LLC on Jan 11, 2011 in Waukesha, 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)
- End Date
- Jan 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waukesha, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 5167 | 21 CFR 1040.10(g)(1)(ii) | Class II "Caution" label |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |