FDA WARNING_LETTER - Country Fresh Orlando, LLC - May 22, 2012

The FDA conducted an inspection of Country Fresh Orlando, LLC's facility on May 21 & 22, 2012, and subsequently reviewed labels for several products, including Fresh Sliced Banana with Strawberry Yogurt Parfait, Strawberry & Blueberry Yogurt Parfait, Fresh Fruit & Yogurt Parfait, and Brushetta. The review found these products to be misbranded under section 403 of the Food Drug and Cosmetic Act and 21 CFR 101. The primary violation cited was the failure of these products to bear a nutrition facts panel as required by 21 CFR 101.9, constituting misbranding under section 403(q) [21 U.S.C. § 343(q)]. Additional deficiencies included inconsistent statement of identity and ingredient statement on the principal display panel for the Strawberry and Blueberry Yogurt Parfait, omission of a street address for the name and place of business on product labels (21 CFR 101.5), and a misspelling ("Strwbry") in the ingredient statement for the Fresh Sliced Banana with Strawberry Yogurt Parfait. The firm is required to respond in writing within fifteen working days, detailing corrective actions, prevention plans, and a timetable for implementation, along with documentation. Failure to correct these violations may result in further regulatory action, such as product seizure or an injunction against the firm's operations.