Nicola Pizza Inc. – FDA Warning Letter, Nov 20, 2009

On June 10, 2010, the FDA issued a Warning Letter to Nicola Pizza Incorporated following an inspection on November 9 and 20, 2009. The inspection revealed insanitary conditions and labeling violations, rendering Nic-o-boli® products adulterated under 21 U.S.C. § 342(a)(4) and misbranded under 21 U.S.C. § 343.

Current Good Manufacturing Practice (CGMP) violations included failure to clean and sanitize food contact surfaces (e.g., can opener, pizza dough mixer, dough portion and press machine), failure to exclude pests (live ants, pest control devices over food), and failure to maintain sanitary facilities (food debris in floor holes, dust on ceilings, broken tiles).

Labeling violations for Nic-o-boli® products included: 1. Failure to declare major food allergens (wheat, milk) as required by 21 U.S.C. § 343(w). 2. Failure to meet requirements for nutrient content claims, specifically "fat free dough and sauce" and "healthy heart," as per 21 U.S.C. § 343(r)(1)(A) and 21 CFR 101.62(b), 101.65(d)(2)(i). 3.