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Posted July 01, 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.

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