FDA WARNING_LETTER - Dante Confections - June 07, 2011

The FDA inspected Dante Confections' food manufacturing facility in North Billerica, Massachusetts, in May and June 2011, revealing serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110) and food labeling violations (21 CFR Part 101). These deficiencies render assorted truffles adulterated under Section 402(a)(4) of the Act due to insanitary conditions, and Peanut Butter Truffle, Peanut Butter Cups, and Nut Oyster products misbranded under Section 403 of the Act. CGMP violations included failure to prevent contamination from production procedures, such as using a common chocolate tempering pot for rework and inadequate segregation of nut/non-nut products (21 CFR 110.80(b)(7)), and failure to clean food contact surfaces, specifically plastic truffle molds, as frequently as necessary (21 CFR 110.35(d)). Labeling violations involved undeclared major food allergens (milk, soy, tree nuts, peanuts) on product labels (Section 403(w) of the Act) and the failure to list all ingredients, including sub-ingredients, in descending order of predominance by weight (Section 403(i)(2) of the Act, 21 CFR 101.4). Additionally, the net quantity content for peanut butter truffle minis was declared only in pieces, lacking required weight, measure, or size information (21 CFR 101.105(c)). Dante Confections must promptly correct these violations and implement preventive procedures, responding in writing within fifteen working days with detailed corrective actions and supporting documentation to avoid further regulatory action.