FDA 483 - Rebel Converting, LLC - February 24, 2024

Rebel Converting LLC, a manufacturer in Milwaukee, WI, was cited for significant deficiencies in its quality control unit and manufacturing processes for OTC monograph drug products, particularly Benzalkonium Chloride wipes. The inspection revealed issues with product testing, stability data, hold time studies, component identity verification, and overall quality unit oversight, indicating a lack of control over product identity, strength, quality, and purity.