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Sani-Care Salon Products, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of over-the-counter hand sanitizer drug products during an October-November 2023 inspection. The company's quality control unit failed to establish adequate procedures and controls to ensure drug products met specifications for identity, strength, quality, and purity, including deficiencies in batch production records, process monitoring, water system validation, and cleaning verification studies. The FDA determined these manufacturing and control failures resulted in adulterated drug products that did not conform to CGMP requirements under federal regulations.