# FDA WARNING_LETTER - Evimeria El Aztecano, Inc. - November 10, 2021

Source: https://www.keypedia.com/records/warning_letter/evimeria-el-aztecano-inc/e0567700-efb2-433c-8b75-4cee75f19402

> FDA WARNING_LETTER for Evimeria El Aztecano, Inc. on November 10, 2021. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Evimeria El Aztecano, Inc.
- Inspection Date: 2021-11-10
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The FDA inspected Yerbas Finas at 1460 W. 135th St., Gardena, CA, from November 2-10, 2021. The inspection and subsequent label review of "Yerbas Finas Leche de Alpiste con Guanabana y Omega-3" revealed multiple violations of the Federal Food, Drug and Cosmetic Act, rendering the product misbranded.

Key violations include:
1. **Misleading Labeling:** Product analysis showed magnesium and potassium levels were below 80% of declared values, violating 21 CFR 101.9(g)(4)(ii).
2. **Unauthorized Nutrient Content Claims:** Claims like "high in protein content" and "as much protein as meat" are made despite the product not meeting the required protein percentages (21 CFR 101.54(b), 101.65(c)(2)).
3. **Improper Nutritional Information Presentation:** The Supplement Facts label fails to comply with 21 CFR 101.36 regarding proprietary blend declaration, ingredient naming/order, calorie declaration, quantitative amounts, formatting, and the use of the 2,000-calorie diet statement.
4. **Incomplete Dual-Language Labeling:** Required information is not repeated in both languages present on the label (21 CFR 101.15(c)).
5

## Related Officers

- [Darla R. Bracy](https://www.keypedia.com/people/darla-r-bracy/ff507c75-ede3-4915-9aea-d8971842d891)

Company: https://www.keypedia.com/companies/evimeria-el-aztecano-inc/b37d9153-4118-4dc9-b2dc-2aa6ae8276de

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b