Casa di Pasta, Inc. – FDA Warning Letter, Apr 10, 2014

On July 23, 2014, the FDA issued a Warning Letter to Casa di Pasta, Inc. following an inspection from March 18 to April 10, 2014. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and misbranding issues under Section 403 of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - **Seafood HACCP Violations:** The firm lacked a HACCP plan for Seafood Ravioli to control pathogenic growth, toxin formation, and undeclared allergens (21 CFR 123.6(a), (b)). Sanitation monitoring was insufficient, with issues like an improper air gap in a 3-compartment sink, dough buildup on equipment after sanitation, and uncovered marinara sauce stored on unclean, rusty shelves (21 CFR 123.11(b)). These render Seafood Ravioli adulterated. - **Labeling Violations:** - **Undeclared Allergens:** Cheese Ravioli failed to declare wheat, a major food allergen, despite using wheat flour (Section 403(w) of the Act). Corrective actions for Stuffed Shells in Marinara were inadequate, missing milk in the "Contains" statement. - **Incomplete Ingredient Lists:** Seafood Ravioli and Cheese Ravioli labels