FDA WARNING_LETTER - Picket Fence Creamery LLC - September 15, 2021

The FDA inspected Picket Fence Creamery in Woodward, Iowa, from September 13-15, 2021, and issued a Warning Letter identifying significant labeling violations. The inspection revealed that twelve flavors of ice cream and three flavors of cheese curds were misbranded under section 403(i)(2) of the Act and 21 CFR 101.4 because their labels failed to declare all ingredients and sub-ingredients. Specific deficiencies included the Dutch Letter! Ice Cream and Key Lime Pie! Ice Cream products not listing sub-ingredients for components like "Dutch letters," "almond syrup," graham crackers, key lime pie filling, and lime syrup. The Key Lime Pie! Ice Cream also improperly listed colors in the "contains" statement, not in descending order of predominance. The Taco! White Cheddar Cheese Curd product failed to declare sub-ingredients for "taco seasoning," and its revised "contains" statement was inaccurate regarding wheat flour. Additionally, the firm failed to include a Nutrition Facts label for its products, as required by 21 CFR 101.9 (unless exempt), and did not list the full street address on revised labels, violating 21 CFR 101.5(d). Although some corrections were made, the product labels remain non-compliant. The FDA requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation, warning that failure to comply could lead to regulatory actions like seizure or injunction.