FDA Inspection
Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics, Inc. – FDA Inspection, May 31, 2017
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics, Inc., with an inspection on May 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bdc63a3b-10b2-4e3a-ac9f-d6475501f23d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1012263
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.70(i)Documentation of software validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Siemens Healthcare Diagnostics, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 12, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Siemens Healthcare Diagnostics, Inc.
- FDA Inspection 1230618 - 2024-05-24
- FDA Inspection 1167476 - 2022-03-30
- FDA Inspection 1141620 - 2021-03-12
- FDA Inspection 896868 - 2014-09-19
- FDA Inspection 827292 - 2013-03-13
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