FDA Inspection
GE Medical Systems Information Technologies, Inc.GE Medical Systems Information Technologies, Inc. – FDA Inspection, Oct 9, 2012
Record Details
This FDA Inspection record concerns GE Medical Systems Information Technologies, Inc., with an inspection on October 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 9, 2012
- Product Type
- Devices
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ID · e14d747b-cb68-49fd-92b1-8324582f7dbd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802525
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
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Other FDA inspections of GE Medical Systems Information Technologies, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GE Medical Systems Information Technologies, Inc.
- FDA Inspection 1059359 - 2018-07-19
- FDA Inspection 849871 - 2013-09-25
- FDA Inspection 679075 - 2010-08-20
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