483
Roy F. ChemalyRoy F. Chemaly – FDA 483, Mar 3, 2021
Record Details
An FDA inspection of Roy F. Chemaly, a clinical investigator in Houston, TX, revealed a significant compliance issue related to clinical trial conduct. The firm failed to report serious adverse events (SAEs) to the study sponsor within the timeframes specified by the study protocols. This indicates a critical lapse in patient safety reporting and adherence to regulatory requirements for investigational drug studies.
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ID · 6fac534a-ae9e-4f0a-8efe-6f01e4781596
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