FDA 483 - NATURE'S FUSIONS, LLC - January 21, 2025

NATURE'S FUSIONS, LLC in Orem, UT was inspected and cited for multiple significant deficiencies in its manufacturing processes for OTC hand sanitizers. The observations primarily concern inadequate quality control, lack of proper stability data for expiration dates, deficient testing of components and finished products for microorganisms and identity, and improper storage conditions. These issues indicate a severe lack of adherence to cGMP requirements, potentially impacting product quality and safety.