FDA 483 - GNT USA LLC - June 03, 2025

An FDA inspection conducted from May 29 to June 3, 2025, at a Natural Color Additive Manufacturer in Dallas, NC, resulted in a Form FDA 483 observation. The primary issue identified was a deficiency in the firm's hazard analysis for liquid finished goods. Specifically, the analysis dated March 7, 2023, failed to recognize the significant hazard of pathogen growth and toxin formation due to inadequate time/temperature control during product storage. The manufacturer produces various color additives from natural ingredients like fruit and vegetable concentrates and spirulina extract. These products do not undergo a lethal treatment, have no studies demonstrating lethality, and are not considered shelf-stable. Although products are stored at a specific temperature, the firm markets them as requiring storage at 50°F, which the FDA deemed insufficient for controlling pathogen growth and toxin formation. This observation indicates a need for the company to reassess and strengthen its food safety plan, particularly concerning preventive controls for finished product storage. The firm is expected to respond to the FDA with corrective actions to address this critical food safety concern, aligning with the Federal Food, Drug, and Cosmetic Act.