King Juice Company., Inc. – FDA Warning Letter, Apr 13, 2011

On August 18, 2011, the FDA issued a Warning Letter to King Juice Company, Inc. following an inspection from April 7-13, 2011, at their Milwaukee, Wisconsin facility. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering their juice products, including Apple, Orange, Grape, Pineapple, Fruit Punch, Pear, and Cranberry Juices, adulterated under 21 U.S.C. § 342(a)(4).

Key HACCP violations included: * **Inadequate Monitoring Procedures:** The HACCP plan for Cold-Filled Juice Products failed to list procedures for monitoring time between product leaving the heating section and entering the regeneration/cooling section, and holding time, at the "Pasteurize" critical control point (21 CFR 120.8(b)(4)). * **Missing Hazard Analysis:** The HACCP plan for Hot Filled 100% Fruit Juices, packaged in glass, did not list the physical hazard of glass fragments (21 CFR 120.8(b)(1)). Control measures for periodic monitoring of processing lines for glass breakage were required. * **Thermal Process Validation:** For hot-fill products, while not requiring a 5-log reduction in the HACCP plan, the firm was