Chlodnia Grudziadz Sp. z o.o. – FDA Warning Letter, Nov 7, 2014

On May 12, 2015, the FDA issued a Warning Letter to Chlodnia Grudziadz Sp. Z o.o. following an inspection on November 6-7, 2014, in Grudziadz, Poland. The inspection found that the company's Krolewski bukiet warzyw, Marchewka z grosckiem, and Zupa Krolewska ze Szpinakiem products violated the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101.

Key violations include: 1. **Misbranding due to undeclared allergens:** The Zupa Krolewska ze Szpinakiem product is misbranded under section 403(w) of the Act because its label fails to declare milk, a major food allergen, despite containing cream derived from cow's milk. 2. **Misbranding due to incomplete English labeling:** All three products are misbranded under section 403(f) of the Act and 21 CFR 101.15(c)(1) because, while containing foreign language, not all required information, such as the statement of identity, is repeated in English. 3. **Misbranding due to incorrect Nutrition Facts panel formatting:** All three products are misbranded under section 403(q)(1) of the Act and 21 CFR 10