483
Lewis, Karl D. MDLewis, Karl D. MD – FDA 483, Aug 7, 2023
Record Details
An FDA inspection of Lewis, Karl D. MD, a clinical investigator in Aurora, CO, revealed significant deviations from the investigational plan and protocol requirements. Observations included failures to properly conduct investigations, maintain accurate case histories, and ensure proper informed consent procedures. These issues indicate serious non-compliance in the conduct of clinical trials.
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ID · 89387a55-c2d7-494b-b9b6-8c60d7543b3a
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