FDA Inspection
GE Medical Systems Information Technologies, Inc.GE Medical Systems Information Technologies, Inc. – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns GE Medical Systems Information Technologies, Inc., with an inspection on July 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 19, 2018
- Product Type
- Devices
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ID · 7ecc4aad-7130-4e6b-9ccb-b82a6f4fe79e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059359
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 806.10(c)(9)Device number, identification
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GE Medical Systems Information Technologies, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 9, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 20, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GE Medical Systems Information Technologies, Inc.
- FDA Inspection 849871 - 2013-09-25
- FDA Inspection 802525 - 2012-10-09
- FDA Inspection 679075 - 2010-08-20
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