483
Prodrome Sciences USA, LLCProdrome Sciences USA, LLC – FDA 483, Jan 10, 2025
Record Details
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.
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ID · 595d49f0-97d1-484c-a444-a4206a88f818
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