FDA 483 - Melaleuca Inc - August 27, 2025
Discuss this record with AI
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.
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.
- Office
- Seattle District Office
- Person
ID · 5ec73c3e-4f8f-4140-a67a-160bbc4dbeb9