FDA Inspection
Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics, Inc. – FDA Inspection, Dec 29, 2011
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics, Inc., with an inspection on December 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 29, 2011
- Product Type
- Devices
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ID · b8741282-dad4-4c5d-a22b-dd6ff0b1fd4b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 762172
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(c)Design input - review and approval
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 |
| May 31, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 19, 2014 | 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 1012263 - 2017-05-31
- FDA Inspection 896868 - 2014-09-19
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