FDA Inspection
GE Healthcare, Inc.GE Healthcare, Inc. – FDA Inspection, Jul 25, 2014
Record Details
This FDA Inspection record concerns GE Healthcare, Inc., with an inspection on July 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GE Healthcare, Inc.
- Inspection Date
- July 25, 2014
- Product Type
- Drugs
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ID · d5ab3264-2168-4b69-b914-acbfcc311133
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 888441
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of GE Healthcare, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 20, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 21, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2010 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 15, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for GE Healthcare, Inc.
- FDA Inspection 819631 - 2013-01-30
- FDA Inspection 794813 - 2012-08-20
- FDA Inspection 672864 - 2010-07-21
- FDA Inspection 649298 - 2010-02-22
- FDA Inspection 620044 - 2009-10-15
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