FDA Inspection
GE Healthcare, Inc.GE Healthcare, Inc. – FDA Inspection, Aug 20, 2012
Record Details
This FDA Inspection record concerns GE Healthcare, Inc., with an inspection on August 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GE Healthcare, Inc.
- Inspection Date
- August 20, 2012
- Product Type
- Drugs
View Company Profile
ID · 4c896f0c-52eb-4ef4-baa3-4093b71ea5e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794813
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GE Healthcare, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 30, 2013 | 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 888441 - 2014-07-25
- FDA Inspection 819631 - 2013-01-30
- FDA Inspection 672864 - 2010-07-21
- FDA Inspection 649298 - 2010-02-22
- FDA Inspection 620044 - 2009-10-15
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