FDA Inspection
Krzysztof W. Selmaj, M.D., Ph.D.Krzysztof W. Selmaj, M.D., Ph.D. – FDA Inspection, Sep 23, 2016
Record Details
This FDA Inspection record concerns Krzysztof W. Selmaj, M.D., Ph.D., with an inspection on September 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 23, 2016
- Product Type
- Drugs
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ID · e97538d4-7309-4b83-8695-a60eb0867825
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989560
- 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 Krzysztof W. Selmaj, M.D., Ph.D.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 26, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 10, 2010 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Krzysztof W. Selmaj, M.D., Ph.D.
- FDA Inspection 946867 - 2015-10-16
- FDA Inspection 850062 - 2013-09-26
- FDA Inspection 666040 - 2010-05-10
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