FDA 483 - Agnitio Inc - June 04, 2021

Agnitio Inc., an OTC Human Drug Manufacturer in Appleton, WI, was inspected by the FDA from June 1-4, 2021. The inspection revealed a significant issue with the firm's stability program, specifically that the Quality unit failed to properly review and verify stability data for certain products. This indicates a potential lapse in quality control for drug products.