FDA Inspection
William D Koltun, MDWilliam D Koltun, MD – FDA Inspection, Feb 24, 2012
Record Details
This FDA Inspection record concerns William D Koltun, MD, with an inspection on February 24, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- William D Koltun, MD
- Inspection Date
- February 24, 2012
- Product Type
- Drugs
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ID · b7b6ed24-bc8b-431a-912b-ce67c6e5935f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775361
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(c)Record retention
- 21 CFR 312.62(a)Unused drug disposition (investigator)
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Other FDA inspections of William D Koltun, MD
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 30, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 2, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for William D Koltun, MD
- FDA Inspection 1082274 - 2019-03-12
- FDA Inspection 1000042 - 2017-01-30
- FDA Inspection 974220 - 2016-06-02
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