Winfrey's Olde English Fudge, Inc. – FDA Warning Letter, Apr 21, 2022

An FDA inspection of a manufacturing facility in Rowley, MA, from March 8 to April 21, 2022, revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The facility produces ready-to-eat (RTE) enrobed chocolates and fudge, including Milk Chocolate Pretzels and Milk Chocolate Peanut Butter Mini Eggs.

The FDA determined that the RTE products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. The facility failed to conduct a comprehensive hazard analysis for all food types, specifically neglecting allergen cross-contact, undeclared allergens due to incorrect labeling, environmental pathogens (Salmonella, Listeria monocytogenes), bacterial pathogens (Salmonella) in RTE ingredients, mycotoxins in ingredients, and metal contamination. An FDA sample of Milk Chocolate Pretzels tested positive for peanut (280 ppm and 104 ppm), despite not listing peanuts as an ingredient, indicating allergen cross-contact.

Additionally, product labels were found to be misbranded under 21 U.S.C. § 343. Violations include: 1. Failure to bear the common or usual name of the food (e.g., "Milk Pretzels," "Milk Peanut Butter Mini Eggs"). 2. Failure