FDA 483 - Rebel Converting, LLC - February 24, 2025

Rebel Converting LLC in Milwaukee, WI, was inspected and cited for significant deficiencies in its manufacturing and quality control processes for OTC Benzalkonium Chloride wipe products. Observations included inadequate testing of active ingredients, lack of a stability program to support expiration dates, and failure to establish hold time limits. Additionally, the firm failed to verify component identity and exhibited a deficient quality control unit with issues in manufacturing controls, testing specifications, OOS tracking, environmental monitoring, deviation investigations, and data integrity.