FDA Inspection
Siemens AG/Siemens Healthcare GmbHSiemens AG/Siemens Healthcare GmbH – FDA Inspection, Jan 26, 2023
Record Details
This FDA Inspection record concerns Siemens AG/Siemens Healthcare GmbH, with an inspection on January 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6aa0e8cc-8e13-453e-8cb3-43c247be1f82
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196666
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Siemens AG/Siemens Healthcare GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2018 | Not classified | Office of Inspections and Investigations | |
| July 19, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 3, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Siemens AG/Siemens Healthcare GmbH
- FDA Inspection 1054153 - 2018-01-12
- FDA Inspection 979352 - 2016-07-19
- FDA Inspection 894799 - 2014-04-03
- FDA Inspection 721737 - 2011-03-03
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