GMP violations for production and quality control still plague supplement makers
Natural Products INSIDER
In the second part of a series on GMP violations, manufacturers of dietary supplements in the United States are struggling with requirements to establish production and process controls to verify the quality of their products. The production and process controls requirements reflect “the most poorly understood section” of FDA’s 10-year-old cGMPs, according to Vasilios (“Bill”) Frankos, Ph.D., an Herbalife Nutrition executive and former FDA official, who oversaw implementation of the dietary supplement manufacturing regulations after they were adopted in 2007. UNPA’s Larisa Pavlick describes some of the essential cGMP requirements and what FDA wants to see during an audit.Read more→
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Current FDA enforcement actions and guidancesKeep up to date on FDA’s current enforcement actions, including general warning letters, recall information and GMP compliance issues, with this link to FDA's website.
Search and sign up for a variety of FDA Guidances.