FDA WARNING_LETTER - Jonlly Fruits, Inc. - October 05, 2010

The FDA inspected Jonlly Fruits, Inc. from September 20 to October 5, 2010, documenting serious violations of juice Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). The company's orange juice concentrate was deemed adulterated due to insanitary conditions.

Key violations include: - **HACCP Plan Failure:** Jonlly Fruits failed to develop a required HACCP plan for orange juice concentrate, despite being a final juice processor and packaging site subject to 21 CFR Part 120 and the 5-log reduction process. - **CGMP Violations:** - Food was not protected from contamination; water dripped into orange juice tanks from an unclean pipeline, and an employee retrieved a valve knob from a mixing tank with bare hands. - Inadequate sanitary facilities: Handwashing sinks lacked hot water and sufficient pressure. - Poor hygienic practices: Employees changed operations from cleaning to adding ingredients without washing hands or changing gloves. - Inadequate cleaning of food-contact surfaces: Residues were found in storage tanks and the filling machine after product changes, and shipping baskets were improperly cleaned. - Improper storage of toxic compounds: Unidentified containers held sanitizing agents, and a household degreaser bottle was used for chlorine sanitizer. -