FDA Inspection
GE Medical Systems, LLCGE Medical Systems, LLC – FDA Inspection, Mar 2, 2012
Record Details
This FDA Inspection record concerns GE Medical Systems, LLC, with an inspection on March 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GE Medical Systems, LLC
- Inspection Date
- March 2, 2012
- Product Type
- Devices
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ID · be6cd806-4fb6-4f6f-a459-96b9fd21b903
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769374
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.70(i)Validation of changes to automated process software
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of GE Medical Systems, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 11, 2011 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for GE Medical Systems, LLC
- FDA Inspection 803966 - 2012-10-11
- FDA Inspection 705630 - 2011-01-11
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