FDA Inspection
Siemens Healthcare Diagnostics IncSiemens Healthcare Diagnostics Inc – FDA Inspection, Aug 21, 2013
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics Inc, with an inspection on August 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 21, 2013
- Product Type
- Devices
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ID · 58b22a90-367c-4654-acec-23eb365cd2f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 846920
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 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(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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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 |
| May 19, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Siemens Healthcare Diagnostics Inc
- FDA Inspection 1149882 - 2021-08-19
- FDA Inspection 663938 - 2010-05-19
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