FDA Inspection
Mark E. Kutner, MDMark E. Kutner, MD – FDA Inspection, May 15, 2015
Record Details
This FDA Inspection record concerns Mark E. Kutner, MD, with an inspection on May 15, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Mark E. Kutner, MD
- Inspection Date
- May 15, 2015
- Product Type
- Biologics
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ID · 65210e80-e2cc-4882-8f67-93c87d3d2d32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927639
- FDA center
- Biologics
- 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 |
| August 28, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 24, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 27, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Mark E. Kutner, MD
- FDA Inspection 1121105 - 2020-03-10
- FDA Inspection 899328 - 2014-08-28
- FDA Inspection 796321 - 2012-08-24
- FDA Inspection 685673 - 2010-10-27
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