FDA Inspection
Mark E. Kutner, MDMark E. Kutner, MD – FDA Inspection, Oct 27, 2010
Record Details
This FDA Inspection record concerns Mark E. Kutner, MD, with an inspection on October 27, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mark E. Kutner, MD
- Inspection Date
- October 27, 2010
- Product Type
- Drugs
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ID · c98fa86f-db62-4a8c-a840-b0c83b042814
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685673
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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Other FDA inspections of Mark E. Kutner, MD
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 15, 2015 | VAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| August 28, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 24, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Mark E. Kutner, MD
- FDA Inspection 1121105 - 2020-03-10
- FDA Inspection 927639 - 2015-05-15
- FDA Inspection 899328 - 2014-08-28
- FDA Inspection 796321 - 2012-08-24
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