FDA 483 - Preventics, Inc. - April 18, 2025

An FDA inspection of Preventics, Inc. dba Legere Pharmaceuticals in Scottsdale, AZ, revealed significant deficiencies across its dietary supplement manufacturing, packaging, and labeling operations. The firm failed to establish and adhere to critical specifications for products, packaging, and components, and exhibited widespread issues with master and batch production records. Furthermore, the inspection identified severe lapses in quality control procedures, product complaint handling, returned product management, and sanitation practices, indicating a systemic failure to comply with good manufacturing practices.