New F.D.A. Guidance to be ‘as Robust and Transparent as Possible’
date:Nov 08, 2018
product a serious risk to public health.

The Food Safety and Modernization Act (FSMA) of 2011 gave the F.D.A. the authority to mandate a recall when a manufacturer refuses to remove from commerce a product that has been deemed unsafe. Before FSMA, the agency had to rely on voluntary recalls by manufacturers. Since the enactment of FSMA, Dr. Gottlieb noted, the F.D.A. has issued only one mandatory recall order.

To assist companies with a product recall, Recall Coordinators are available to ove
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