FDA WARNING_LETTER - Agrovillaserra, S.L. - May 26, 2014

The FDA inspected Agrovillaserra S.L. in Spain on May 26, 2014, finding violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101 for their Villagos Artisan Manchego Cheese and Villagos Manchego Cheese products.

The Villagos Artisan Manchego Cheese product is misbranded because its label fails to declare eggs, a major food allergen from egg lysozyme used in manufacturing, as required by Section 403(w) of the Act. Both Villagos Artisan Manchego Cheese and Villagos Manchego Cheese products are misbranded under Section 403(q) for lacking nutrition information as required by 21 CFR 101.9, having expired Small Business Nutrition Labeling Exemption notifications. Additionally, the Villagos Artisan Manchego Cheese product is misbranded under Section 403(i)(2) because egg lysozyme, an ingredient, is not declared on the label, violating 21 CFR 101.4.

The FDA also noted that the "Contains" allergen statements for both products incorrectly declare milk as an allergen, as they are made from sheep's milk, not cow's milk. Furthermore, the net quantity of contents statements do not meet 21 CFR 101.105 requirements due to the use of "minimum."

Failure to respond adequately may result in refusal of admission