FDA 483 - Fruit Of The Earth, Inc. - December 22, 2021

Fruit Of The Earth Research Laboratories, Inc. in Grand Prairie, TX, was inspected and cited for multiple significant deficiencies related to the manufacturing and control of its aloe vera products, including acidified foods and dietary supplements. The firm failed to establish scheduled processes, manage process deviations, and ensure product specifications and scientifically valid testing methods. Additionally, the firm's environmental controls were inadequate, posing potential risks of microbial contamination.