# FDA 483 - Melaleuca Inc - August 09, 2019

Source: https://www.globalkeysolutions.net/records/483/melaleuca-inc/11a453bd-916f-4da6-a9b5-2481c5d95de7

> FDA 483 for Melaleuca Inc on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Melaleuca Inc
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Melaleuca, Inc. in Idaho Falls, ID was inspected by the FDA from August 6-9, 2019, resulting in two observations. The inspection revealed significant issues with the firm's production and process controls, specifically regarding process validation, and deficiencies in laboratory instrument calibration procedures. These findings indicate a moderate level of non-compliance with good manufacturing practices.

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## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822