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Posted April 11, 2013

Chinese Herbal Manufacturer Warned For CGMP Violations

On March 20, 2013, the FDA issued a warning letter to Finemost Corporation, dba Qualiherb, following a facility inspection which found the company's supplements, including Yi Zhi Tang and C. Aquino's Happy Pregnancy for Vadevali and Eva Vives products, to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements.

These violations include failure to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient prior to its use, failure to establish specifications for each component used in the manufacture of a dietary supplement, and failure to establish and follow written procedures for quality control operations.

The FDA also stated that Qualiherb's attempt to correct these violations was inadequate.

Yi Zhi Tang and C. Aquino's Happy Pregnancy for Vadevali and Eva Vives supplements were also found to be misbranded as the labels do not provide all the information required by federal regulations. Specifically, the labels did not list the number of servings per container, did not identify the part of the plant botanical ingredients were derived from, and failed to list the common or usual name of botanical ingredients.

See Related Warnings:

FDA Warns of Medical Claims Made For Numerous Chinese Herbal Products

Chinese Herb Recalled Due To Undeclared Sulfites

Herbal Supplement Company Warned For Manufacturing Violations and Drug Claims