FDA 483 - Melaleuca Inc - May 14, 2025

Melaleuca Inc. in Knoxville, TN, was cited with a Form FDA 483 following an inspection of its OTC drug manufacturing facility. The primary concern identified was the firm's failure to conduct adequate identification testing on raw material components, such as glycerin, and an insufficient supplier qualification program. These deficiencies indicate a potential risk to the quality and safety of their OTC drug products.