FDA 483 - RMLC Industries LLC dba Mr. Lulu LLC - December 09, 2022

Mr. Lulu LLC, a manufacturer of OTC drug products like Mr. Lulu Sunscreen Drops in Claremont, CA, was cited with five observations during an FDA inspection. The firm demonstrated severe deficiencies across its quality system, facilities, equipment, and production controls, including the complete absence of a quality control unit, lack of essential testing, and no written procedures or validation for critical manufacturing processes. These issues indicate a fundamental lack of adherence to Good Manufacturing Practices, raising significant concerns about product quality, safety, and purity.