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* You are viewing Posts Tagged ‘import’

FDAImports.com Opens Manila, Philippines Office

admin May 06, 2013 Company News, Cosmetics, Dietary Supplements, Drugs, Food, Imports, Law & Regulatory, Medical Devices No Comments

Tags: ASEAN, ben england, export, import, Manila, offices, Olivia Zuniga, Philippines

manila-philippines-office

FDAImports.com has opened a new expansion office in Manila, Philippines.  Manila is strategically located to allow FDAImports.com to handle client needs in the South Pacific – Malaysia, Indonesia, Thailand, Vietnam, and more.  The United States is one of the Philippines’ top trading partners, importing billions of dollars of machinery, apparel, and agricultural products.  “The Philippines export prime agricultural products to the United States,” said Ben England, Founder and CEO of FDAImports.com, “such as tropical oils, sugar cane, processed fruit and vegetables, tree nuts, and fruit and vegetable juices.”

“FDA’s regulatory interest in … READ MORE

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Partnership Interview: Rick Gilmore, Chairman of the Global Food Safety Forum (GFSF)

admin May 08, 2012 China, Company News, Food, Imports No Comments

Tags: china, export, FSMA, GFSF, Global Food Safety Forum, government, import, non-profits, partners, Rick Gilmore, training

Rick Gilmore, GFSFWe’d like to take a moment to introduce one of our partners here at FDAImports.com, the Global Food Safety Forum (GFSF), a 501(c)(3) focused on establishing dialogue, training, and private-public collaboration in all areas of food safety, imports and the food supply chain.  Founded and managed by GIC Group President/CEO and Chairman of GFSF, Rick Gilmore, GFSF creates key opportunities between the U.S. and China such as training events, workshops, delegation visits, consulting services, and research projects. We … READ MORE

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FDAImports.com Overcomes Import Alerts and Other Obstacles: 2 Success Stories

admin July 20, 2011 Company News, Imports, Law & Regulatory No Comments

Tags: 23-14, 86-07, aflatoxin, alert, case studies, contamination, delays, FDA, food, import, import alert, mold, releases, shipments, snacks, sunglasses, testing

FDA Import Alerts

FDAImports.com recently declared victory for two clients with many shipments of products under FDA automatic detention due to FDA Import Alerts.  An Import Alert will always cause shipment delays, supply-chain risks, increased costs and budget overages, not to mention the additional burden it places on a supplier to prove to FDA why they should not be on Import Alert.  FDAImports.com is pleased to report on two recent success stories of obtaining removal from FDA Import Alert on relatively short time frames.
Case #1: Sunglasses (Import Alert #86-07)
FDA began automatically … READ MORE

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FDA Clarifies its Concerns about Medical Devices from Japan

admin June 03, 2011 Law & Regulatory, Medical Devices No Comments

Tags: animal electrical, CBER, CDRH, Center for Biologic Evaluation and Research, Center for Device and Radiological Health, compliance, detention, documentation, drug, earthquake, exporters, FDA, food, import, inspection, inspections, japan, laboratory, medical devices, mold, regulation, regulatory, safety, sterile, sterilization, temperature control, testing, united states, violations, water

FDA Medical Device RegulationIn 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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Former FDA Regulatory Counsel Helps Japanese Exporters Know What To Expect In Post-Tsunami Setting

admin June 03, 2011 Company News, Law & Regulatory No Comments

Tags: affects, aftershock, ben england, compliance, compliant, documentation, drug, earthquake, effects, export, FDA, fdaimports.com, food, fukushima, impact, import, imports alert, Insights For Japanese Exporters, inspection, japan, medical devices, nuclear radiation, regulation, regulatory, sendai, supply, testing, tremor, tsunami, upstream, usda

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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Benjamin England to Present at the FDLI US-China Food and Drug Law Conference in June 2011

admin May 18, 2011 Company News, Law & Regulatory No Comments

Tags: beijing, Ben, china, drug, England, fdli, fee, food, import, institute, law, modernization act, products, recalls, regulations, regulatory, safeety, safety, trade, us

FDLI Logo ChinaThe FDAImports.com and ExporttoUSA.com.cn team is eagerly preparing for the Food and Drug Law Institute (FDLI) US-China Food and Drug Law Conference.   This conference, taking place in Beijing, China on June 13 and 14 2011, will bring expert thinkers and top government officials together to discuss food and drug regulation and policy in the United States and China.  This event is hosted by FDLI and FDAImports.com is a platinum sponsor along with GE Healthcare, Pfizer and Medtronic.   Mr. Benjamin England, founder and CEO of … READ MORE

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Earthquake Will Cause Importers of FDA-Regulated Products From Japan to Face New Hurdles

admin March 15, 2011 Imports 1 Comment

Tags: attorneys, beverages, cGMP, dietary, drugs, earthquake, exports, facility, FDA, food, import, imports, inspections, japan, medical devices, safety, supplements, united states

japan city downtown before earthquake

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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