Lodato Gennaro & C S.p.A. – FDA Warning Letter, Nov 20, 2012

On March 7, 2013, the FDA issued a Warning Letter to Lodato Gennaro & C S.p.A. following an inspection on November 19-20, 2012, at their facility in Italy. The inspection revealed significant labeling and Good Manufacturing Practice (GMP) violations, rendering several products adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Misbranding due to undeclared allergen:** "Annalisa Zuppa Di Farro" failed to declare wheat, a major food allergen, despite containing "spelt." This violates Section 403(w) of the Act. 2. **Improper nutrition facts labeling:** Numerous "Annalisa" and "LaCastellina" products had nutrition labels that did not meet formatting requirements (21 CFR 101.9(d)), omitted mandatory nutrients, failed to round values correctly, and used improper serving size declarations (21 CFR 101.9(b)(5), 101.12(b)). Additionally, some products incorrectly provided a percent Daily Value for trans fat. 3. **Failure to repeat required information in multiple languages:** "Annalisa Zuppa Di Orzo Perlato," "Annalisa Zuppa Di Farro," and "Annalisa Zuppa Di Grano Saraceno" labels