Chicago Supplement Firm Runs Out Of Chances To Correct GMP, Label Violations
This article was originally published in The Rose Sheet
Executive Summary
"Despite repeated promises to fix the problems, Defendants have not done so. Accordingly, the United States now seeks a permanent injunction to bring Defendants’ operations into compliance with the law," US attorneys say in a complaint. Global Marketing Enterprises enters consent decree with FDA requiring that before resuming manufacturing and distributing supplements, it implement remedial measures to brings its operations into compliance.
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The firm’s owners “are well aware that their conduct violates the law and that continued violations could lead to regulatory action,” DoJ says in complaint requesting a permanent injunction to prohibit it from making and distributing supplements until it complies with FDA GMP and labeling regulations.