FDA WARNING_LETTER - Abruzzino's Italian Bakery, LLC - September 21, 2009

The FDA conducted an inspection of Abruzzino's Italian Bakery, LLC in Gypsy, West Virginia, on September 16 and 21, 2009, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and misbranding issues under section 403 of the Federal Food, Drug, and Cosmetic Act. The bakery's products were deemed adulterated due to insanitary conditions. Key CGMP violations included failure to exclude pests and properly store waste (21 CFR 110.35(c), 110.37(f)), failure to maintain ingredient and dough containers to prevent contamination (21 CFR 110.80(b)(7)), and inadequate precautions to exclude personal items like drugs, tobacco, and beverages from production areas (21 CFR 110.10(b)(9)). Additionally, employees failed to wear appropriate outer garments (21 CFR 110.10(b)(1)) and effective hair restraints (21 CFR 110.10(b)(6)). The firm's Abruzzino's Pepperoni Roll with Cheese (6 oz) product was misbranded because it failed to declare milk, a major food allergen, as an ingredient (Section 403(w) of the Act), and did not declare all sub-ingredients for multi-ingredient components like American cheese and pepperoni (Section 403(i)(2) of the Act, 21 CFR 101.4(b)(2)). The FDA acknowledged the firm's response but found it inadequate. Abruzzino's must respond within 15 working days with specific corrective actions and documentation, or face potential product seizure and injunction.