Preventics, Inc. – FDA 483, Apr 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.
- Office
- Denver District Office
- Person
ID · 649200d3-5e1a-4bde-b01b-bb47030452ab
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.