Prodrome Sciences USA, LLCJanuary 10, 2025

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

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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.

Company: Prodrome Sciences USA, LLC
Inspection Date: January 10, 2025
Product Type: Drugs
Office: Los Angeles District Office
Person: Samson O. Oluseye

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ID · 595d49f0-97d1-484c-a444-a4206a88f818