483
Prof. Mariusz Kruk, M.D. Ph.D.Prof. Mariusz Kruk, M.D. Ph.D. – FDA 483, Sep 13, 2019
Record Details
Prof. Mariusz Kruk, M.D. Ph.D., a clinical investigator in Warsaw, Poland, received a Form 483 for significant deficiencies observed during an FDA inspection. The findings primarily concern inadequate record-keeping for case histories and poor accountability for investigational drug disposition. These issues highlight serious concerns regarding data integrity and control over study materials.
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