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Compliance with FDA Requirements: What Are Executives Thinking or Not Thinking??

Recently, Novartis took a “$120m charge to improve a US manufacturing plant and recall drugs after the FDA sent it a 483”. For those uninitiated in FDA-speak, form 483 is used by the FDA to document and communicate concerns discovered during factory inspections. In this case, Novartis recalled bottles of Excedrin, Bufferin, Gas-X and NoDoz … Continue reading →