FDA Inspection
Siemens Medical Solutions USA, Inc.Siemens Medical Solutions USA, Inc. – FDA Inspection, Apr 15, 2016
Record Details
This FDA Inspection record concerns Siemens Medical Solutions USA, Inc., with an inspection on April 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 15, 2016
- Product Type
- Devices
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ID · af234197-0a3d-40af-8d78-657f3a781312
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976280
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(b)Review and evaluation for investigation
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Other FDA inspections of Siemens Medical Solutions USA, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2017 | Not classified | San Francisco District Office | |
| March 27, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 10, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 19, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Siemens Medical Solutions USA, Inc.
- FDA Inspection 1022705 - 2017-04-06
- FDA Inspection 916426 - 2015-03-27
- FDA Inspection 839435 - 2013-07-10
- FDA Inspection 759664 - 2011-12-19
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