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Product Imports Major Challenge for FDA

FDA is experiencing a serious challenge in the face of a wave of imported product recalls, especially those coming from China. "We have to get a handle on it," said Gail Costello, acting director of FDA's New England District Office.

Transforming FDA LogoFDA is experiencing a serious challenge in the face of a wave of imported product recalls, especially those coming from China. "We have to get a handle on it," said Gail Costello, acting director of FDA's New England District Office. Costello, who spoke at MassMEDIC's annual FDA Update event on Friday, implied that resources have been part of the issue when dealing with imported products. About 28% of FDA-regulated imports are medical devices and radiological health products. Product recalls, including those beyond medical devices, put a strain on FDA district offices. For example, there are normally about 5000 consumer complaints per year. During the pet recall last summer, FDA received 19,000 complaints in a three month period. More than half of the New England district staff had to work on the recall, thus pulling resources away from other areas. According to Costello, part of the government's efforts to address the problem is to "prevent, intervene, and respond." The Import Safety Plan consists of an interagency working group that is roadmapping an action plan to improve the safety of imported products. Costello says this plan is a major focus of FDA's Office of Regulatory Affairs in both the short and long term.
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