FDA 483 - Melaleuca Inc - August 27, 2025

An FDA inspection of Melaleuca Inc. in Idaho Falls, ID, revealed significant deficiencies in their drug manufacturing operations. The firm was cited for inadequate cleaning validation, poor documentation practices including backdating records, and failure to perform required component identification tests. Additionally, issues with equipment design leading to standing water and uncalibrated analytical equipment were observed, indicating a lack of control over critical processes.