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Inovaker Lab S.A. de C.V. was cited for manufacturing Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, an unapproved new drug that was adulterated due to subpotency—its active ingredient strength fell below the labeled 75% concentration—indicating failure of quality assurance systems to meet Current Good Manufacturing Practice (CGMP) requirements. The product was detained and refused admission at the U.S. border during an import attempt, and FDA testing confirmed the strength, purity, and quality deficiencies. The company was also cited for misbranding the product and introducing it into interstate commerce without FDA approval, violations of sections 505(a), 502(a), and 502(ee) of the Federal Food, Drug, and Cosmetic Act.