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Mr. Lulu LLC, a drug manufacturer in Claremont, California, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of OTC Mr. Lulu Sunscreen Drops SPF32. The company failed to perform adequate release testing on finished drug product batches prior to distribution, specifically neglecting to test for zinc oxide and titanium dioxide content—the active ingredients—and instead only evaluating products for scent, appearance, and texture without documented procedures or written protocols. The firm's December 2022 response to FDA's initial inspection findings was deemed inadequate due to insufficient detail and lack of evidence demonstrating corrective actions necessary to achieve compliance.