FDA WARNING_LETTER - Royal Wine Corporation - November 13, 2014

The FDA inspected Royal Wine Corporation's juice processing facility from November 5-13, 2014, and found serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These violations render their "Grape Juice," "Grape Juice Mevushal," "Apple & Cranberry Juice," "Apple Juice," and "Cranberry Juice" adulterated under Section 402(a)(4) of the Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The firm failed to identify all reasonably likely food hazards, such as microbiological hazards (bacterial contamination/growth) in grape, apple, and cranberry juices, and the physical hazard of metal. The hazard analysis for grape juice did not recognize or identify critical control points for pasteurization, despite the firm selling pasteurized grape juice. 2. **Lack of 5-Log Reduction Control:** The HACCP plan for "All Juice and Wine" products lacked an adequate process control measure to consistently achieve a 5-log reduction of the pertinent microorganism, as required by 21 CFR 120.24(b). Labeling a product as requiring pasteurization is not an adequate control without a written agreement with the receiving firm acknowledging responsibility for the 5-log kill step. 3. **Insufficient Record Keeping:** The firm did not maintain records