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Sombra Cosmetics, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in its manufacturing of over-the-counter drug products including topical analgesic creams and hand sanitizers. The company failed to establish adequate written procedures for production and process control and did not adequately demonstrate that water used in manufacturing and equipment cleaning met United States Pharmacopeia specifications, including failures to conduct proper TOC and conductivity testing with multiple microbiological samples showing excessive contamination ("TNTC" - too numerous to count). The FDA found the company's August 2024 response to inspection findings inadequate, citing insufficient supporting documentation and lack of evidence demonstrating corrective actions to achieve CGMP compliance.