Albanese Confectionery Group, Inc. – FDA EIR, Feb 24, 2017

The FDA conducted a comprehensive inspection of Albanese Confectionery Group, Inc. in Merrillville, IN, from February 13 to February 24, 2017, under Domestic Food Safety and General Food Labeling programs. The inspection resulted in a 3-point FDA-483, detailing significant violations, two of which were repeat observations from a 2010 inspection.

Key issues included a "Failure to handle work-in-progress in a manner that protects against contamination." This involved sequential roasting of various nuts and seeds in the same oil without adequate filtration or documented oil changes, and re-working chocolate scrapings containing undeclared allergens into other products, risking cross-contamination. A "Failure to clean food-contact surfaces and utensils as frequently as necessary" was observed, with soiled utensils and inadequate procedures to prevent allergen cross-contamination when switching products. Finally, a "Failure to store finished food under conditions that would protect against deterioration" involved packing oil-roasted macadamia nuts directly into unlined cardboard, leading to oil saturation and potential microbial contamination.

Management acknowledged the observations and committed to addressing them, including reviewing nut roasting practices, implementing improved allergen control protocols, acquiring color-coded cleaning utensils, and exploring new nut drying methods. The company was required to provide a written response to the FDA-483 within 15 days, outlining their corrective actions.