FDA Inspection 976280 — Siemens Medical Solutions USA, Inc.
The FDA completed an inspection of Siemens Medical Solutions USA, Inc. on April 15, 2016 in Mountain View, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 15, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mountain View, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |