FDA WARNING_LETTER - Perfection Bakeries Inc, dba Aunt Millie's Bakeries - March 20, 2023

The FDA issued a Warning Letter to Mr. Popp regarding "Our Family" brand White Hot Dog Enriched Buns, manufactured between February 9, 2023, and March 20, 2023. The product was recalled on March 21, 2023, due to misbranding under section 403(w) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(w)], as the label failed to declare sesame, a major food allergen as of January 1, 2023.

The firm reformulated the buns in January 2023 to include sesame. However, incorrect packaging without sesame declared was received on February 9, 2023, and used for production until March 20, 2023. The issue was discovered after a customer reported an allergic reaction. The root cause was identified as "lack of label control," with incorrect packaging accepted and used.

The firm's action plan includes retraining bag operators, break people, and supervisors on allergen label checks; updating policy for QA manager verification of all bag receipts; requiring new bag numbers for future allergen labeling changes; and mandating company sign-off on new packaging proofs. The FDA will verify these corrective actions during a future inspection. The letter also notes that the firm is subject to CGMP and PC rule (21 CFR Part