Flavors from Florida, Inc. – FDA Warning Letter, Sep 16, 2011

On January 4, 2012, the FDA issued a Warning Letter to Flavors from Florida, Inc. following an inspection of their Bartow, FL juice processing facility from September 12-16, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their diluted juice beverages adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Cleaning and Sanitizing:** Utensils and equipment parts were stored in an iodine solution with insufficient concentration (21 CFR 110.35(d)(5)). 2. **Cross-Contamination:** * An employee wore the same plastic apron outside and then continued processing (21 CFR 110.10(b)(1)). * A trash dumpster was observed in the Blending room, approximately ten feet from processing activities (21 CFR 110.80(b)(6)). * Employees returned from break without washing hands, and an iodine hand-dipping bucket had inadequate concentration (21 CFR 110.10(b)(3), 110.10(b)(5)). * Employees in Fill and Blending rooms did not wear hairnets