Safety Problem Plus GMP Warnings Equal Increased Likelihood Of DoJ Action

Ignoring good manufacturing practices warnings landed Triceuticals Inc. in hot water with FDA, and a consumer’s kidney failure associated with a product containing “high levels of vitamin D” helped catch the Department of Justice’s attention.

Triceuticals and its president, Liqun Zhang, agreed to a consent decree permanently preventing them from manufacturing and distributing adulterated dietary supplements, DoJ announced July 9. The decree entered in New...