483
Gilberto M. Cruz, M.D.Gilberto M. Cruz, M.D. – FDA 483, Apr 24, 2024
Record Details
Reliable Clinical Research Llc in Hialeah, FL, a clinical investigator, received a Form FDA 483 with two observations. The firm failed to conduct an investigation in accordance with the investigational plan, specifically by enrolling a subject who did not meet inclusion criteria. Additionally, the firm did not prepare or maintain accurate case histories, showing discrepancies in recorded assessment times and electronic source data.
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ID · cc33383b-4a71-4a5e-8239-d4e3603ce55a
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