Evimeria El Aztecano, Inc. Warning Letter Details

Summary

Evimeria El Aztecano, Inc. received a warning for misbranding its "Yerbas Finas Leche de Alpiste con Guanabana y Omega-3" dietary supplement, which failed to contain declared levels of potassium and magnesium—both Class II minerals that must be present at no less than 80% of labeled values under 21 CFR 101.9(g)(4)(ii). The product's label also bore nutrient content claims that did not meet FDA requirements under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act, making the labeling false or misleading. The FDA conducted its inspection at the company's Gardena, California facility from November 2-10, 2021, and the company submitted a response to the FDA's Form 483 observations in February 2022.