FDA WARNING_LETTER - Dutch-Maid Bakery - October 25, 2013

An FDA inspection of Dutch Maid Bakery in Tracy City, Tennessee, conducted from October 21-25, 2013, revealed serious violations of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 110. These conditions caused the firm's food products to be adulterated per Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to insanitary conditions. Key violations included widespread rodent and insect activity, inadequate pest exclusion, improper use of exposed rodenticides, and insanitary facility conditions with soiled floors and equipment. The firm also failed to properly store food (on floors, near agricultural lime), maintain sufficient space for sanitary operations, and ensure structural integrity for easy cleaning. Exterior sanitation was poor, creating pest harborage, and rubbish disposal was inadequate. Further deficiencies involved contaminated equipment/utensils, improper storage of toxic pesticides, lack of hair restraints for employees, and personal clothing in washing areas. The firm's November 18, 2013, response indicated corrective actions, some voluntarily initiated during the inspection. FDA requires a comprehensive written response within 15 working days detailing specific corrective and preventive actions, including documentation and timetables. Failure to promptly correct these issues may result in regulatory actions like seizure or injunction, and the firm may incur re-inspection fees.