Supplier qualification is a requirement of the regulations, as set out by 21 CFR part 111.75. Setting up a proper supplier qualification program is an essential step in maintaining dietary […] Read More >>
By: Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements Although many companies are aware of the need to have dietary supplement liability insurance, it is also important […] Read More >>
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements On July 16, 2012, the U.S. Food & Drug Administration (FDA) filed an injunction against a New York […] Read More >>
What is FDA Form 483? The FDA has started conducting inspections of establishments that manufacture, process, pack, or hold dietary supplements without prior notice to determine the establishment’s compliance with […] Read More >>
Current Good Manufacturing Practices (cGMPs) for Dietary Supplements have been in effect since June 2010 and the FDA has been increasing inspections each year since. In 2011, 145 FDA inspections […] Read More >>
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