FDA Inspection
Siemens Medical Solutions USA, Inc.Siemens Medical Solutions USA, Inc. – FDA Inspection, Aug 27, 2026
Record Details
This FDA Inspection record concerns Siemens Medical Solutions USA, Inc., with an inspection on August 27, 2026, issued by the Seattle District Office, covering medical devices & rad health.
- Inspection Date
- August 27, 2026
- Product Type
- Medical Devices & Rad Health
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ID · ab5445f4-4057-4e94-a469-3dba6d467087
Inspection Facts
- Inspection number
- 1325694
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- ISO 13485:2016 Clause 8.4Data analysis did not include data from monitoring, measurement, other sources
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Siemens Medical Solutions USA, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 6, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 12, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 4, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Siemens Medical Solutions USA, Inc.
- FDA Inspection 1228210 - 2024-01-31
- FDA Inspection 1194297 - 2023-01-06
- FDA Inspection 907597 - 2014-12-12
- FDA Inspection 883159 - 2014-06-04
- FDA Inspection 792025 - 2012-07-27
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