FDA WARNING_LETTER - Bake’N Joy Foods, Inc. - November 03, 2020

The FDA issued a Warning Letter to a firm for failing to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). This non-compliance is prohibited by section 301(uu) of the Act.

The firm recalled Sienna brand Cranberry Orange Flavored Muffin Batter on May 19, 2020, after a customer reported the presence of undeclared walnuts. The product is not formulated to contain walnuts, and they were not declared on the label. The incident occurred when a batch of cranberry nut batter, which contains walnuts, was added into the depositor hopper with cranberry orange batter.

The primary violation identified was the failure to identify and implement preventive controls to significantly minimize or prevent the hazard of undeclared allergens from cross-contact at the mixing/depositor step, as required by 21 CFR 117.135(a)(1) and (c)(2).

The firm indicated in a May 22, 2020, email that they implemented corrective actions, including retraining operators and supervisors on batch "dropping" procedures, and performed a voluntary destruction of recalled product. The FDA will verify these corrective actions during the next inspection.

The firm is required to take prompt action to correct the violations. Failure to do so may result in regulatory action, including seizure and injunction. A written response detailing corrective