FDA 483 - Melaleuca Inc - May 10, 2019

Melaleuca, The Wellness Company, an OTC drug manufacturer in Knoxville, TN, was cited with seven observations during an FDA inspection from May 6-10, 2019. The inspection revealed significant deficiencies across multiple areas, including process validation, complaint handling, employee training, laboratory controls, supplier qualification, quality control unit procedures, and master production records. These issues indicate a lack of robust quality systems necessary for consistent drug product quality and compliance with cGMP regulations.