FDA Inspection
Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics, Inc. – FDA Inspection, Apr 23, 2014
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics, Inc., with an inspection on April 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 23, 2014
- Product Type
- Devices
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ID · 4ff06f98-1bf2-4350-9e75-4eccf0097eb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 875518
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Siemens Healthcare Diagnostics, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2024 | Not classified | Philadelphia District Office | |
| December 17, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 9, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Siemens Healthcare Diagnostics, Inc.
- FDA Inspection 1278130 - 2024-05-14
- FDA Inspection 813459 - 2012-12-17
- FDA Inspection 768876 - 2012-02-09
- FDA Inspection 585525 - 2009-05-08
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