FDA Inspection
Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics, Inc. – FDA Inspection, Jan 4, 2012
Record Details
This FDA Inspection record concerns Siemens Healthcare Diagnostics, Inc., with an inspection on January 4, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 4, 2012
- Product Type
- Devices
View Company Profile
ID · d6d5981f-3f7d-4afe-8059-4b339a5d2b6a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 754929
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
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 |
| March 2, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 |
Other documents for Siemens Healthcare Diagnostics, Inc.
- FDA Inspection 1163970 - 2022-03-08
- FDA Inspection 1043709 - 2018-03-02
- FDA Inspection 1018565 - 2017-05-12
- FDA Inspection 929757 - 2015-05-20
- FDA Inspection 821920 - 2013-02-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.