FDA WARNING_LETTER - Cut Fruit Express, Inc. - December 18, 2009

The FDA inspected Cut Fruit Express, Inc. in Inver Grove Heights, Minnesota, from December 15-18, 2009, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The firm was found in violation of juice Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 120), Current Good Manufacturing Practices (21 CFR Part 110), and food labeling regulations (21 CFR Part 101). Consequently, their 100% orange and grapefruit juices are deemed adulterated and misbranded. Key deficiencies include the absence of written HACCP plans and a Hazard Analysis for their juices (21 CFR 120.8(a)). The firm failed to achieve a validated five-log pathogen reduction, using an unproven surface treatment without scientific documentation of efficacy (21 CFR 120.12(a)(5), 120.24(b)). Additionally, the company improperly labeled its citrus juice products with a warning statement, despite being subject to HACCP regulations (21 CFR 101.17(g)(2)(ii)). There was also a failure to analyze finished juice products for biotype I Escherichia coli as required for indirect treatments (21 CFR 120.25). Furthermore, the firm lacked Sanitation Standard Operating Procedure (SSOP) records for monitoring sanitation conditions, including protection from adulteration and control of employee health (21 CFR 120.6(c), 120.12(a)(1)). Monitoring of processing conditions and practices was insufficient, evidenced by product buildup on a juice extractor, lack of hot water at an employee hand sink, and an unlabeled barrel of sodium hypochlorite (21 CFR 120.6(b)). The FDA requires a written response within 15 working days detailing corrective actions to prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.