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Berkeley Nutraceuticals warned

This article was originally published in The Tan Sheet

Executive Summary

Discrepancies between the declared weight of Berkeley's Rovicid and Enzyte tablets and their actual weight causes the products to be misbranded and "may indicate a systemic problem in your manufacturing processes," according to an Oct. 14 warning letter sent by FDA's Cincinnati office. FDA also cited the firm for promoting its manufacturing facility as "certified by [FDA] for Good Manufacturing Practices," a false statement causing Berkeley's products to be further misbranded. Moreover, heart disease treatment claims for Rovicid and age-related macular degeneration claims for Rogisen cause the products to be unapproved new drugs...





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