In a previous FDAImports.com article on the Japan Earthquake it was stated that FDA-regulated products from Japan will likely face many new hurdles in order to enter the United States. FDA will likely subject them to greater regulatory review by inspecting incoming food, drugs and medical devices and possibly subjecting them to laboratory testing.

On June 1, 2011, the Center for Device and Radiological Health (“CDRH”) and the Center for Biologic Evaluation and Research (“CBER”) issued a … READ MORE

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Companies that are directly affected by a major natural disaster or weather event, such as the Joplin, Missouri tornadoes or the earthquake and tsunami in Japan, should expect a heightened level of federal and state oversight in the future especially when it comes to facilities, documentation and equipment.

1. Facilities: Facility integrity will be a major factor in assessments including warehousing, manufacturing plants and other structures related to the import/export process.  Exporters must know precisely the extent of … READ MORE

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Benjamin L. England, a former 17-year veteran of the FDA and former Regulatory Counsel, posted a video

today offering his insights into what Japanese exporters should expect in the coming months as they attempt to export products to the United States after the recent earthquakes and tsunami.  In light of the import alert issued by the FDA Mr. England states that, “Even for products that are not on the alert the FDA is conducting testing,” and that FDA scrutiny will be on … READ MORE

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FDAImports.com, LLC, consultants and affiliated attorneys have been thinking about and praying for all of our friends, colleagues and clients affected by the massive earthquake and tsunami which struck Japan on March 11th. We wanted to provide an update on the affect of these events upon those importing FDA-regulated products to the United States from Japan. Certainly the earthquake in Japan will exact personal, social, and economic consequences that will be with us for many years. More particularly, this will have long-term … READ MORE

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