FDA Inspection
Siemens Healthcare Diagnostics IncSiemens Healthcare Diagnostics Inc – FDA Inspection, May 19, 2010
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics Inc, with an inspection on May 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 19, 2010
- Product Type
- Devices
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ID · 728927f7-be89-47e5-a657-63cb9835903b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663938
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Siemens Healthcare Diagnostics Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Siemens Healthcare Diagnostics Inc
- FDA Inspection 1149882 - 2021-08-19
- FDA Inspection 846920 - 2013-08-21
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