FDAImports.com Founder and CEO, Benjamin England, recently led a webinar in conjunction with seafoodsource.com entitled, “Ensuring the Safety of Japanese Seafood.”  This webinar addressed the state of food safety and seafood coming from Japan as industry resumes and picks up again following the tsunami and earthquake in the spring.  Mr. England addressed the issue, identifying key factors such as FDA’s import alerts, HARPC, FDA examinations and private testing of exports.  Additional discussion centered on the coming FDA … READ MORE

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36 million pounds of ground turkey. 

That’s a ton of meat, 18,000 tons of meat to be precise. That’s the weight of 120 million brand-new iphones (without the box).  So if almost everyone in Japan bought an iphone-4 today and then put them all on a scale, that’s how much the recalled turkey meat would weigh.

Confused yet? Good.

An importer or manufacturer goes through this same kind of mental trauma every second of every day during a recall or … READ MORE

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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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According to research done by www.FDAImports.com, The U.S. Food and Drug Administration (“FDA”) aggressively stepped-up the number of food-facility inspections in China last year according to the FDA Inspection Classification Database. Between fiscal year 2009 and 2010, FDA had a thirteen-fold increase in food-facility inspections in China. Last year’s dramatic increase foreshadows FDA’s greater international profile through inspecting foreign food-facility, which Congress mandated in the recently passed FDA Food Safety Modernization Act (“FSMA”).

China has played an increasingly important role in supplying food to the United States. Between 1999 and 2008, China went from the eleventh-largest supplier of … 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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