Kerber, Inc. – FDA Warning Letter, Feb 14, 2013

The FDA inspected Kerber Inc.'s facility in North Huntington, PA, from February 6-14, 2013, reviewing labels for various ice cream and a juice product. The inspection revealed significant misbranding violations under sections 403 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Parts 74 and 101. Specifically, Cherry Chocolate Chip, Chocolate Freckles, and Mint Chocolate Chip ice cream products were misbranded for failing to declare major food allergens (soy) as required by section 403(w). The Cherry Chocolate Chip ice cream was also misbranded under section 403(i)(2) and 21 CFR 101.4 for not declaring sub-ingredients. The Jungle Juice Orange Drink was misbranded for failing to state the total percentage of fruit juice, per 21 CFR 101.30. Cherries Jubilee and Strawberry ice cream products were misbranded under section 403(k) and 21 CFR 101.22(k) for not declaring artificial colorings (FD&C Red No. 40, FD&C Blue No. 1). Additionally, Muddy Sneakers, Cherry Chocolate Chip, and Butter Pecan ice cream products lacked required Nutrition Facts panels, violating 21 CFR 101.9. The firm's submitted revised labels did not address these violations. Kerber Inc. must take prompt action to correct all violations and respond in writing within fifteen working days, providing documentation of corrections. Failure to comply may result in regulatory actions like seizure, injunction, and re-inspection fees. The letter emphasizes the firm's responsibility for full compliance with FDA regulations.