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LS Promotions Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter drug products, including SPF 15 lip balm, SPF 30 sunscreen, and hand sanitizer. The company failed to conduct adequate laboratory testing of each batch prior to release to verify identity, strength of active ingredients, and microbiological safety—violations of 21 CFR 211.165(a) and (b)—resulting in adulterated drug products distributed to the U.S. market. The FDA conducted an inspection at the Ronkonkoma, NY facility from April 24 to May 2, 2024, and issued the warning letter on August 5, 2024, after reviewing the company's response submitted on May 15, 2024.