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Cosmax NBT USA, a dietary supplement manufacturer in Garland, Texas, failed to establish required product specifications for identity, purity, strength, and composition of finished batches, including a multimineral product, in violation of Current Good Manufacturing Practice (CGMP) regulations under 21 CFR 111.70(e). The inspection conducted from April through May 2021 identified serious violations of the Federal Food, Drug, and Cosmetic Act that rendered the dietary supplements adulterated because they were prepared and held under conditions that did not meet FDA's CGMP requirements. The company submitted multiple written responses between May 2021 and July 2022 attempting to address the FDA's inspectional observations, but the violations were deemed serious enough to warrant the warning letter issued in May 2023.