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

During an inspection conducted from November 30 to December 9, 2022, the FDA identified significant compliance issues at Mr. Lulu LLC, a manufacturer of drug products like Mr. Lulu Sunscreen Drops, located in Claremont, CA. The inspection revealed a lack of adherence to essential regulatory requirements, specifically current Good Manufacturing Practices (cGMP). Key observations included the complete absence of a quality control unit, which led to a failure in testing raw materials, in-process goods, and finished products for identity, strength, quality, and purity. There were no written procedures for quality unit responsibilities, complaint handling, recalls, or deviation investigations. Furthermore, the company lacked a stability program and failed to assign expiration dates for its OTC drug products. Additional concerns involved equipment and facility management, with observations noting inadequate cleaning validation for manufacturing equipment (which was also used for personal food preparation), no written cleaning procedures or records, and a lack of equipment qualification for the mixer used in production. The firm also failed to establish written production and process control procedures, including process validation, and did not maintain complete batch production and control records, such as material identification, quantities, weights, and lot numbers for distributed products. Mr. Lulu LLC is required to address these serious deficiencies to ensure the safety, quality, and efficacy of its drug products.