FDA Inspection
Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics, Inc. – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics, Inc., with an inspection on March 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 78d76ed0-3af9-4834-b942-f2ecff7019a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043709
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Siemens Healthcare Diagnostics, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 20, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 4, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Siemens Healthcare Diagnostics, Inc.
- FDA Inspection 1163970 - 2022-03-08
- FDA Inspection 1018565 - 2017-05-12
- FDA Inspection 929757 - 2015-05-20
- FDA Inspection 821920 - 2013-02-20
- FDA Inspection 754929 - 2012-01-04
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