FDA 483 - Prodrome Sciences USA, LLC - January 10, 2025

An FDA inspection of Prodrome Sciences USA, LLC in Temecula, CA, conducted from December 2024 to January 2025, revealed a significant compliance issue. The firm failed to submit an Investigational New Drug (IND) application to the FDA before initiating a clinical investigation involving an investigational new drug. This resulted in 29 subjects being enrolled and 22 completing a study without proper regulatory oversight.