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FDA proposes new rules for food, drug, device recalls

Recalls of food, drugs and medical devices continue to make headlines as the Food and Drug Administration (FDA) works to implement the Food Safety Modernization Act (FSMA) and focus on compliance with current good manufacturing process (CGMP) requirements with all FDA-regulated products. As part of this effort, in January 2013 the FDA proposed a rule that would require manufacturers of food to maintain a recall plan that would evaluate the severity and scope of the recall; notify the FDA, consumers and the public; and secure insurance coverage for potential losses and liabilities. Manufacturers with no experience writing recall plans or ... Read More