FDA EIR - Fruit of the Earth Inc. - October 10, 2023

An unannounced surveillance inspection of Fruit of the Earth Inc. was conducted by the FDA on October 10, 2023, at its Fort Worth, TX facility. This inspection, part of the FY24 FSMA Tier 2 program, aimed to assess the company's compliance with 21 CFR Part 117, covering Current Good Manufacturing Practices for human food. Fruit of the Earth Inc. operates multiple facilities, manufacturing aloe vera drinks, human over-the-counter topical drug products, and cosmetics. While the inspected Fort Worth location primarily handles bundling of packaged aloe vera drinks for shipment and stores raw ingredients like purple carrot juice (though none were present during the inspection), the actual manufacturing of food products occurs at a separate Grand Prairie facility. Significantly, the inspection concluded without any observations of non-compliance. No FDA Form 483 Inspectional Observations were issued, indicating that the facility was found to be operating in accordance with regulatory requirements at the time of the inspection. No samples were collected, and no refusals were encountered. Management confirmed the company's registration as an acidified food processor across its facilities. This positive outcome suggests Fruit of the Earth Inc. maintained satisfactory adherence to the inspected good manufacturing practices and regulatory standards.