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Posted May 14, 2014

Maker of Mood, Smoking Cessation Supplements and More Warned for Violations, Drug Claims

On April 17, 2014, the FDA issued a warning letter to CDJ Holding, Incorporated, d.b.a. Pacific BioLogic, following a facility inspection which found the company's products, including Grounded, Limbic Balance Morning Formula, Limbic Balance Evening Formula, TobacOff, and JittersAway, 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 establish identity specifications for each component used in the manufacture of a dietary supplement and failure to design a production and in-process control system to ensure that dietary supplements are manufactured in a manner that will ensure the quality of the dietary supplement.

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