Evimeria El Aztecano, Inc.

Warning LetterOpen

Michael A. Vizcarrondo Owner Evimeria El Aztecano, Inc. 1460 W. 135th St. Gardena , CA 90249-2218 United StatesFEI 3011900429Issued Nov 16, 2022Division of Human and Animal Food Operations West V

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011900429.

Violations18

Issue DateNov 16, 2022

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: Evimeria El Aztecano, Inc.
Location: Michael A. Vizcarrondo Owner Evimeria El Aztecano, Inc. 1460 W. 135th St. Gardena , CA 90249-2218 United States
FEI Number: 3011900429
Country: United States
Issue Date: November 16, 2022
Issuing Office: Division of Human and Animal Food Operations West V
Product Type: Dietary Supplements
Status: Open

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.

Evimeria El Aztecano, Inc. FDA Warning Letter, November 16, 2022