483
Parvez MantryFDA 483 - Parvez Mantry - November 14, 2023
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Record Details
An FDA inspection of The Liver Institute at Methodist Dallas, a clinical investigator site, revealed a significant deficiency in their investigational plan. The firm failed to report Serious Adverse Events (SAEs) to the sponsor or designee within the required 24-hour timeframe, as stipulated by their own protocol. This lapse in timely reporting was observed across multiple study subjects, indicating a failure to adhere to critical safety reporting procedures.
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ID · 2120ba30-a661-48c1-a43e-9525f78d5fb7