FDA Inspection 1059359 — GE Medical Systems Information Technologies, Inc.
The FDA completed an inspection of GE Medical Systems Information Technologies, Inc. on Jul 19, 2018 in Milwaukee, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 19, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4202 | 21 CFR 806.10(c)(9) | Device number, identification |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |