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Posted November 28, 2014

Seller of Herbal Extracts Warned for Manufacturing Violations, Drug Claims

On November 3, 2014, the FDA issued a warning letter to Avena Botanicals, Inc., following a facility inspection which found the company's products, including Black Cohosh Root Liquid Extract, Gotu Kola Liquid Extract, and Echinacea Root Liquid Extract to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. 

These violations include failure to ensure the quality of dietary supplements the company distributes, failure to ensure that the dietary supplements are packaged and labeled as specified in the master manufacturing record, and failure to prepare or follow a written master manufacturing record for each unique formulation of dietary supplement manufactured.

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