FDA WARNING_LETTER - Chris A Papas and Son Co - January 30, 2015

An FDA inspection conducted from January 21-30, 2015, at Chris A. Papas and Sons Co.'s food manufacturing facility in Covington, KY, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and misbranding violations (21 U.S.C. § 343, 21 CFR Part 101). These deficiencies render the firm's food products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key adulteration violations included failure to protect food from contamination during packaging, specifically cross-contamination of allergens due to inadequate cleaning between production runs. Employees were observed not washing hands thoroughly, and the cleaning and sanitizing procedure for equipment was deemed inadequate, lacking a detergent. Misbranding violations for Papa's Chocolate Covered Easter Eggs products were extensive. Labels failed to declare all major food allergens completely and accurately (e.g., wheat, milk, egg, soy, pecans) as required by 21 U.S.C. § 343(w). Ingredient lists were incomplete, lacking sub-ingredients (e.g., chocolate liquor, cocoa butter, vanilla, specific colors) and using general terms like "nuts" or "fruit" instead of specific names (21 U.S.C. § 343(i)(2), 21 CFR 101.4). Nutrition information panels were not in the correct format (21 U.S.C. § 343(q), 21 CFR 101.9), and the term "cream" was not declared in ingredient statements for certain products (21 U.S.C. §343(i)(1)). The firm was advised on potential small business nutrition labeling exemptions. The FDA may assess reinspection fees due to the identified food safety noncompliance. The firm must respond to the FDA with corrective actions.