Modavar PharmaceuticalsNovember 15, 2024

FDA 483 - Modavar Pharmaceuticals - November 15, 2024

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An FDA inspection of Modavar Pharmaceuticals, LLC in Frederick, MD, revealed a significant deviation from established protocols. The firm failed to implement blinding procedures for analysts during IVRT studies, as required by their own Blinding Protocol. This indicates a lapse in adherence to internal study conduct procedures.

Company: Modavar Pharmaceuticals
Inspection Date: November 15, 2024
Product Type: Drugs
Office: Baltimore District Office
Person: Sylvestre K. Dossou

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ID · 13b5b9d8-3b1b-4a65-b0aa-c2286d4278b8