483
Melaleuca IncMelaleuca Inc – FDA 483, Aug 27, 2025
Record Details
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
View Company Profile
ID · 5ec73c3e-4f8f-4140-a67a-160bbc4dbeb9
Other documents for Melaleuca Inc
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.