# FDA 483 - Melaleuca Inc - August 27, 2025

Source: https://www.keypedia.com/records/483/melaleuca-inc/5ec73c3e-4f8f-4140-a67a-160bbc4dbeb9

> FDA 483 for Melaleuca Inc on August 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Melaleuca Inc
- Inspection Date: 2025-08-27
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: 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.

## Related Documents

- [483 - 2019-08-09](https://www.keypedia.com/records/483/melaleuca-inc/11a453bd-916f-4da6-a9b5-2481c5d95de7)

## Related Officers

- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)

Company: https://www.keypedia.com/companies/melaleuca-inc/78b84c92-611c-44d2-918d-86b78836afad

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913