FDA WARNING_LETTER - Hans Bakery, Inc. dba Andersen's Bakery - November 04, 2024

The FDA issued a Warning Letter to Hans Bakery Inc. d/b/a Andersen’s Bakery following an inspection from October 15 to November 4, 2024. The inspection revealed significant violations related to food safety and sanitation. The agency found the facility"s ready-to-eat (RTE) bakery, dessert products, and RTE vacuum-packaged tuna salad to be adulterated, as they were prepared and held under insanitary conditions, including the presence of rodent and insect filth throughout the production areas.

Major issues included a failure to comply with seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice and Risk-Based Preventive Controls for Human Food (21 CFR Part 117). Specifically, the company lacked a proper HACCP plan for its RTE refrigerated vacuum-packaged tuna salad to control serious food safety hazards like scombrotoxin/histamine formation, bacterial pathogen growth (including Clostridium botulinum), and undeclared allergens such as egg and fish. Observations during the inspection noted inadequate temperature control during the manufacturing, packaging, and storage of tuna salad, increasing the risk of pathogen growth. Furthermore, the tuna salad and saffron raisin twist products were misbranded due to violations of food labeling regulations (21 CFR Part 101), lacking essential information like a statement of identity, ingredients, and allergen declarations.

The FDA requires Hans Bakery to implement a comprehensive and effective HACCP plan for all seafood products, establish robust preventive controls, eliminate all insanitary conditions, and correct all labeling deficiencies to prevent further adulteration and misbranding of their products. The company"s initial response to the inspection observations was deemed inadequate, necessitating more thorough corrective actions.