FDA 483 - Prolifix Nutrition, LLC - May 28, 2021

Prolifix Nutrition in Hurricane, UT, was inspected by the FDA from May 25-28, 2021, resulting in seven observations. The inspection revealed significant deficiencies in quality control operations, product and component specifications for dietary supplements, and incomplete batch production records. Additionally, the firm lacked a written food safety plan and hazard analysis for its nutritional products, indicating serious concerns regarding product quality and safety.