FDA 483 - Vladimir A. Guevara Vazquez, M.D. - June 30, 2023
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An FDA inspection of Clinical Trial Services in Miami, FL, identified significant issues in the conduct of clinical studies. The firm failed to maintain adequate and accurate case histories, exhibiting multiple data discrepancies across subject admissions, health evaluations, and lab collection times. Additionally, the inspection revealed a failure to ensure informed consent was provided in a language understandable to subjects, specifically for Spanish-speaking participants.
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