FDA’s Office Of Regulatory Affairs Scrutinizes Recalls Process
This article was originally published in The Rose Sheet
ORA sets a 2012 priority of improving the efficiency of the recall process to help reach its overall enforcement and compliance goal of preventing public health emergencies.
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Final guidance on mandatory recall authority under FSMA specifies how FDA allows firms opportunities for voluntary recalls and evidence it may consider when deciding whether to mandate a recall. But a consumer advocacy group critical of FDA says the guidance adds nothing for protecting public health.
McKinsey & Co’s. study recommends FDA accelerate internal communications about recalls and consider outsourcing audit checks to follow-up on more. FDA commissioned the study after the heparin recall in 2008 and the peanut products recall in 2009 revealed flaws in the agency’s system.
The Government Accountability Office is urging FDA to clarify and strengthen its oversight of medical device recalls.