RMLC Industries LLC dba Mr. Lulu LLC – FDA Warning Letter, Dec 9, 2022

The FDA inspected Mr. Lulu, LLC's drug manufacturing facility from November 30 to December 9, 2022, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug product adulterated. The company's December 13, 2022, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Failure to perform adequate release testing (21 CFR 211.165(a))**: Mr. Lulu Sunscreen Drops SPF32 batches were released without adequate testing of active ingredients (zinc oxide, titanium dioxide). The firm stated they do not perform assay testing on OTC finished drug products, only evaluating scent, appearance, and texture, with no documented results or written procedures for release. 2. **Failure to test incoming components and validate supplier analyses (21 CFR 211.84(d)(1) and (2))**: The firm did not adequately test incoming components for identity and lacked a written supplier qualification procedure. Food-grade titanium dioxide was used without ensuring it conformed to USP specifications. 3. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a) and 21 CFR 211.188)**: * **Process Validation**: No validation of manufacturing processes, lacking data for parameters like mixing speed,