# FDA 483 - Melaleuca Inc - May 10, 2019

Source: https://www.globalkeysolutions.net/records/483/melaleuca-inc/39055707-8689-4d12-b769-a95b5c9b4fe7

> FDA 483 for Melaleuca Inc on May 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Melaleuca Inc
- Inspection Date: 2019-05-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Melaleuca, The Wellness Company, an OTC drug manufacturer in Knoxville, TN, was cited with seven observations during an FDA inspection from May 6-10, 2019. The inspection revealed significant deficiencies across multiple areas, including process validation, complaint handling, employee training, laboratory controls, supplier qualification, quality control unit procedures, and master production records. These issues indicate a lack of robust quality systems necessary for consistent drug product quality and compliance with cGMP regulations.

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## Related Officers

- [Susan O. Oladeji](https://www.globalkeysolutions.net/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.globalkeysolutions.net/companies/melaleuca-inc/408e4e7c-daa2-41be-be23-05ed2ec5ff2c

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7