Traditional Medicinals, IncApril 12, 2018

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Explore Traditional Medicinals, Inc

Record Details

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.

Company: Traditional Medicinals, Inc
Inspection Date: April 12, 2018
Product Type: Other
Office: Division of Human and Animal Food Operations - West V
People: Thomas N. Adjabeng
Siobhan A Gallagher
Capri R Woolridge

Open in Dashboard

ID · 5a7a1ecd-7208-4baa-82e7-2040f7687040