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MCACO, LTD, a dietary supplement manufacturer in Grand Prairie, Texas, failed to meet Current Good Manufacturing Practice (CGMP) requirements, resulting in adulterated products. During an FDA inspection from November to December 2021, the company did not establish adequate finished product specifications for identity, purity, strength, and composition as required by 21 CFR 111.70(e), lacking numerical limits, ranges, or other defined acceptance criteria for their testing procedures. These serious violations of the Federal Food, Drug, and Cosmetic Act rendered their dietary supplement products adulterated and non-compliant with manufacturing standards.