FLECHARD S.A.S. – FDA Warning Letter, Feb 20, 2015

On October 20, 2015, the FDA issued a Warning Letter to Flechard S.A.S. following an inspection on February 19-20, 2015, in La Chapelle D’andaine, France. The inspection found that several products, including Pure Butterghee, Butter Ghee Natural Milk, Frentel Bueurre Demi-Sel, and Bessofier unsalted butter, violated the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101.

Key violations include: 1. **Misbranding (Allergen Declaration):** Bessofier unsalted butter and Frentel Bueurre Demi-Sel failed to declare milk, a major food allergen, as required by Section 403(w) of the Act. 2. **Misbranding (Ingredient Declaration):** Frentel Bueurre Demi-Sel lacked a complete ingredient statement, violating Section 403(i)(2) and 21 CFR 101.4. The use of "lactic starters" was also deemed inappropriate. 3. **Misbranding (Standard of Identity):** Frentel Beurre Demi Sel and Bessofier products were misbranded under Section 403(b) because they were offered as "butter" but contained bacterial cultures, which do not conform to the statutory definition of butter (21 U.S