Posted October 25, 2013

Supplement Company Warned For Numerous Manufacturing Violations

On August 2, 2013, the FDA issued a warning letter to DNE Nutraceuticals, Inc., following a facility inspection which found the company's products to be adulterated because they were packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish specifications for finished dietary supplements, failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement and failure to establish and follow written procedures for the responsibilities of the quality control operations. The FDA also noted that dietary supplement components were stored outside designated areas, such as in hallways, and that equipment and utensils used in the manufacturing process were not properly cleaned and sanitized.

See Related Warnings:

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