# FDA 483 - Traditional Medicinals, Inc - April 12, 2018

Source: https://www.globalkeysolutions.net/records/483/traditional-medicinals-inc/5a7a1ecd-7208-4baa-82e7-2040f7687040

> FDA 483 for Traditional Medicinals, Inc on April 12, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Traditional Medicinals, Inc
- Inspection Date: 2018-04-12
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Traditional Medicinals Inc., a dietary supplement manufacturer in Sebastopol, revealed significant deficiencies in their quality control documentation. The firm failed to establish complete product specifications, theoretical yields in master manufacturing records, and cross-references for tests and examinations. Additionally, batch production records lacked essential information regarding equipment maintenance.

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Company: https://www.globalkeysolutions.net/companies/traditional-medicinals-inc/6ac503e9-e8eb-4e9a-acdb-f3f86be37038

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b