ARMINAK SOLUTIONS LLC. – FDA 483, Nov 3, 2023

Adonis Inc., a manufacturer and repacker in Corona, CA, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to establish adequate production and process controls, including process validation and equipment qualification, and demonstrated poor control over material testing, quality unit responsibilities, and labeling. These issues indicate a lack of adherence to Good Manufacturing Practices, posing risks to drug product quality and safety.