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

Nature’s Fusions LLC, located at 57 North 1380 West, Orem, Utah, was inspected by the FDA from January 15 to 21, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in Title 21 CFR parts 210 and 211. The violations led to the classification of the company’s drug products as adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key issues identified include the absence of a written testing program to assess the stability of drug products, inadequate material storage conditions, and failure to test incoming raw materials for identity, purity, and strength. Specifically, expired ethanol hand sanitizer gel was repackaged without proper stability studies, and bulk totes were stored outdoors, exposing them to temperature excursions beyond specified limits. Additionally, the firm relied on suppliers" certificates of analysis without validating their reliability.

The FDA requires Nature’s Fusions LLC to address these deficiencies by establishing a comprehensive stability program, ensuring proper storage conditions, and conducting thorough testing of raw materials and finished products. The company must also validate its water system and implement routine testing to prevent microbiological contamination.

Nature’s Fusions has indicated plans to cease manufacturing certain drug products and may not renew its registration as an OTC drug manufacturer. If the company intends to resume manufacturing, it must notify the FDA and demonstrate compliance with CGMP regulations, potentially with the assistance of a qualified consultant.