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Posted July 1, 2014

Maker of Elderberry Concentrate Warned for Manufacturing Violations

On June 23, 2014, the FDA issued a warning letter to Wyldewood Cellars Inc., following a facility inspection which found the company's Elderberry Concentrate to be adulterated because it was prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. 

These violations include failure to prepare and follow a written master manufacturing record for each unique formulation and batch size of a dietary supplement, failure to establish an identity specification for each component used in the manufacture of a dietary supplement and failure to use hygienic practices necessary to protect against contamination of components, dietary supplements, or contact surfaces.

In 2011, U.S. Marshals seized elderberry juice concentrate distributed by Wyldewood Cellars after the company made drug claims about its elderberry juice products.

See the Elderberry Supplements Review for tests of related products.

See Related Warnings:

FDA Seizes Elderberry Juice Concentrate Due to Unproven Claims

Maker of Liquid Supplements Warned For Manufacturing Violations and Drug Claims

FDA and FTC Warn: Supplements Cannot Prevent, Treat Or Cure Cold And Flu

To read the FDA's warning, use the link below.