FDA Inspection
Medi Physics Inc. dba GE Health Care Inc.Medi Physics Inc. dba GE Health Care Inc. – FDA Inspection, Jan 9, 2013
Record Details
This FDA Inspection record concerns Medi Physics Inc. dba GE Health Care Inc., with an inspection on January 9, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 9, 2013
- Product Type
- Drugs
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ID · 2175c178-f9b2-420a-b629-b6831ab4a29e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 812977
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 212.110(b)Record quality
- 21 CFR 212.61(b)Use of stability test results
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.50Adequate controls (general)
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Other FDA inspections of Medi Physics Inc. dba GE Health Care Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 27, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Medi Physics Inc. dba GE Health Care Inc.
- FDA Inspection 1079180 - 2018-12-18
- FDA Inspection 983018 - 2016-07-27
- FDA Inspection 736178 - 2011-06-21
- FDA Inspection 661332 - 2010-05-12
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