FDA WARNING_LETTER - Liberty Fruit Co Inc DBA Carol's Cuts - December 02, 2022

The FDA inspected Liberty Fruit Co Inc. DBA Carol’s Cuts in Kansas City, KS, from November 7 to December 2, 2022, where the company manufactures 100% juices, salsa, and RTE cut produce. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering the manufactured juice products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary violation was the failure to validate the HACCP plan's adequacy after process changes, specifically formulation changes to Tangy Turmeric, Smooth Avocado, and Citrus Sunrise juices in December 2021. The company did not notify their Processing Authority of these changes, which involved different percentages of ingredients, when sending samples for re-evaluation in January 2022.

A subsequent review by the Processing Authority, prompted by the FDA, found a significant pH increase (more than (b)(4) units) in Smooth Avocado juice, which could necessitate a new HPP validation study due to its impact on microbial lethality. Additionally, Citrus Sunrise and Tangy Turmeric juices experienced increased °Brix levels (from (b)(4) to (b)(4) and (b)(4) to (b)(4) respectively), which can enhance microorganism pressure resistance, yet HPP parameters were not revalidated.