FDA Inspection
Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics, Inc. – FDA Inspection, Feb 9, 2012
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics, Inc., with an inspection on February 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 9, 2012
- Product Type
- Devices
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ID · e27c6cd4-9f7c-4c88-9b41-4f9144b19b24
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 768876
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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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 | |
| April 23, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 17, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 875518 - 2014-04-23
- FDA Inspection 813459 - 2012-12-17
- FDA Inspection 585525 - 2009-05-08
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