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The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more
The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...more