FDA 483 - Soft Gel Technologies Inc - June 14, 2023

An FDA inspection of Soft Gel Technologies Inc, an animal food and dietary supplement manufacturer, revealed a significant quality control issue related to the manufacturing of animal food. The firm produced "Omega V3 EFA Softgels Small/Medium Breed" with superpotent Vitamin A concentrations, leading to customer recalls. Additionally, the company lacked procedures to scientifically establish safe nutrient levels for the animal products it manufactures.