FDA EIR - Craftmark Bakery, LLC - October 15, 2021

An FDA inspection of Craftmark Bakery, LLC in Indianapolis, IN, was conducted from October 13-15, 2021. This comprehensive, limited-scope inspection focused on preventative controls and sanitary human food operations, aligning with good manufacturing practices. While no formal inspectional observations (FDA-483) were issued, three key areas were discussed with management for improvement. These included inadequate procedures for handling green rags used on food contact surfaces, which lacked designated storage for clean/dirty items and presented a cross-contamination risk. Concerns also arose regarding insufficient identification and segregated storage practices for allergen ingredients in a tightly packed dry storage room, posing a potential for cross-contact. Furthermore, the inspection noted moderate to heavy debris accumulation in hard-to-reach areas of dry ingredient storage and inactive Cookie Line equipment, indicating sanitation deficiencies. The inspection also reviewed the company's response to a recent Reportable Food Registry (RFR) event involving undeclared tree nuts in chocolate chip cookie dough, which prompted a product recall. The root cause was attributed to spilled nuts contaminating adjacent chocolate chips during storage. In response, Craftmark Bakery had already implemented corrective actions, including enhanced cleaning, revised allergen storage protocols (physical separation), and updates to its Allergen Management Program and associated employee training. Management committed to addressing the other discussion points, including assessing rag usage, evaluating allergen staging practices for better control, and revising cleaning schedules and training for thorough sanitation, with a planned update to their food safety plan to incorporate allergen storage risks.