FDA WARNING_LETTER - Rowley's South Ridge Farms, Inc. - September 30, 2010

On September 28-30, 2010, the FDA inspected Rowley's South Ridge Farms, Inc.'s juice processing facility in Santaquin, Utah, and found serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These deviations render their refrigerated apple and cherry juice products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to establish written HACCP plans for refrigerated South Ridge Farms Red Tart Cherry Juice Concentrate (to control pathogen growth and require a written hazard analysis) and Red Barn Cider Mill Fresh Pressed Pasteurized Apple Juice (to control patulin and pathogen growth). The "HACCP plan for Apple Based Production" presented was incomplete, lacking critical control points, critical limits, and monitoring procedures. 2. **Inadequate Sanitation Standard Operating Procedure (SSOP) Records:** The firm did not maintain SSOP records documenting monitoring and corrections for critical sanitation areas, including water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, protection from contaminants, toxic compound management, employee health conditions, and pest exclusion. 3. **Failure to Apply 5-log Reduction in a Single Facility:** The firm is not performing a 5-log pathogen reduction measure for its refrigerated South Ridge Farms