Chicago Supplement Firm Runs Out Of Chances To Correct GMP, Label Violations
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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.