FDA 483 - Parvez Mantry - November 14, 2023

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.