FDA Inspection
Michael W. Harris, D.O.Michael W. Harris, D.O. – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Michael W. Harris, D.O., with an inspection on May 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c12a0a79-23c1-420a-8048-f81e2f569094
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091037
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(a)Accountability records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Michael W. Harris, D.O.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 29, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 3, 2011 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Michael W. Harris, D.O.
- FDA Inspection 959266 - 2015-12-15
- FDA Inspection 898295 - 2014-08-29
- FDA Inspection 732501 - 2011-05-03
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