FDA Inspection
Siemens Medical Solutions USA, Inc.Siemens Medical Solutions USA, Inc. – FDA Inspection, Mar 27, 2015
Record Details
This FDA Inspection record concerns Siemens Medical Solutions USA, Inc., with an inspection on March 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 27, 2015
- Product Type
- Devices
View Company Profile
ID · 66e3492e-2c6e-4842-b3e7-2a3bc2104e80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916426
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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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 | |
| April 15, 2016 | 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 976280 - 2016-04-15
- FDA Inspection 839435 - 2013-07-10
- FDA Inspection 759664 - 2011-12-19
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