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* You are viewing Posts Tagged ‘united states’

Talking About the Food Safety Modernization Act is a Mouthful. Here’s the Outtakes Reel to Prove it

admin February 04, 2013 Food, Food Safety Modernization Act, Humor, Law & Regulatory 2 Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

Talking about the Food Safety Modernization Act is hard work.  It’s hard to understand, hard to pronounce, hard to summarize and even harder to have some fun with.  But it’s what we do at FDAImports.com all the time.  Although our final videos appear poignant and polished it’s not always an easy road to get there.  In this short video please enjoy a hilarious outtakes reel from our latest FSMA video shoot starring Founder and CEO, Ben England.

Outtakes: FSMA Video Shoot, January 2013

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New Video: Impact of FSMA Proposed Rules on Importers and Foreign Suppliers

admin February 04, 2013 Food, Food Safety Modernization Act, Imports, Law & Regulatory No Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

In this new FSMA training video, Ben England, Founder and CEO of FDAImports.com, shares his unique insights into the recently released Proposed Rules for HARPC and Standards for Produce Safety under FSMA with an eye toward their impact on importers and foreign suppliers, specifically.  This video discusses some key areas of concern for importers and foreign suppliers and how to prepare for coming changes in the food import landscape.

Just for Importers and Foreign Suppliers: FSMA January 2013 Update

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New Video: What You Probably Missed in the Standards for Produce Safety Proposed Rule

admin February 04, 2013 Food, Food Safety Modernization Act, Law & Regulatory No Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

As part of a new FSMA video series, Ben England, Founder and CEO of FDAImports.com, makes some valuable observations on the Proposed Rule for Standards for Produce Safety and explores some ways that industry can begin aligning themselves with FDA’s thinking.

Food Safety Modernization Act: Standards for Produce Safety Update, January 2013

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Watch our other January 2013 FSMA video updates:

HARPC FSMA Proposed Rule

HARPC Proposed Rule

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New Video: Four Key Insights Into the New HARPC Proposed Rule (FSMA)

admin February 04, 2013 Food, Food Safety Modernization Act, Law & Regulatory No Comments

Tags: ben england, FDA, fdaimports.com, FDCA, food, food and drug administration, food safety modernization act, FSMA, HARPC, hazard analysis, imports, law, legislation, Preventive Controls, produce, Proposed Rule, risk based, safety, united states

By now the food industry should have a general grasp of the new Proposed Rules for HARPC and Standards for Produce Safety released by FDA this January 4th under FSMA.  If you are looking for an overview please read these blogs on HARPC, Produce Safety and cGMP changes first.  As part of a new FSMA video series, this new video on the Hazard Analysis and Risk-Based Preventive Controls Proposed Rule, explores some key areas of impact that may not be immediately apparent.  Ben England, Founder and CEO of FDAImports.com, discusses HARPC as well as Standards … READ MORE

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Looking for the FDA Accession Number Database? It Doesn’t Exist so Read This Carefully

admin November 13, 2012 Law & Regulatory, Medical Devices No Comments

Tags: accession number, CDRH, contact, customs form 2877, database, detainment, electronic, emitting, FDA, imports, law, look up, products, radiation, shipment, united states

FDA Accession Number Database Lookup

If you distribute or import radiation-emitting electronic products, you may have already heard of FDA’s accession number system.  However, we have found that many importers are perplexed when they are required complete Customs Form 2877 which, in part, asks the importer to supply an accession number if the imported product is subject to FDA performance standards.  “Where can I look up the accession numbers for my products?” is a very common question we receive at this point in the importation process.  The answer is … READ MORE

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We Apologize For This Ludicrous Chart

admin October 06, 2011 Humor No Comments

Tags: billionaires, chart, charts, FDA attorneys, FDA consultants, funny, graphs, how to import to the usa, humor, resources, united states, vacation

Here at FDAImports.com, we are committed to developing quality blogs, articles, whitepapers, documents, videos and resources for our industry.  We want to make useful content that’s relevant, unique and full of good information that helps our clients, partners, friends and colleagues. But sometimes you just need to take a break, turn off your brain and have a good laugh.  With that being said, here is our humorous contribution to the world of charts, graphs and imports… The “So You Want To Import Something To The United States” flowchart. We hope it helps you… or at least helps you laugh.

[caption id=”attachment_412″ … READ MORE

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Who’s Going to Pay For New FDA Fees? Join The Club Taxpayers!

admin August 29, 2011 Imports, Law & Regulatory No Comments

Tags: america, examination, FDA, federal register, food, food and drug administration, food safety, import alerts, imports, markets, notice, petition, prices, re-examination, shipment, tax dollars, taxes, taxpayer, united states

On October 1st, 2011, FDA will implement a new fee/examination structure that will radically affect the cost of food importing, food prices and the overall burden on taxpayers.  This new structure (tax) will require every significant food import with a questionable food safety issue to be “examined” by FDA and then undergo an expensive re-examination process in order for that shipment to be released; Even if there was no problem with the shipment whatsoever.  The reason is because FDA is cleverly defining the first “free examination” as merely data-retrieval.  It’s not an examination at all.  The real examination … 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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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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Recently Published FDA Import Refusal Report May Cause Complications for Foreign Manufacturers

admin March 02, 2011 Imports, Law & Regulatory 1 Comment

Tags: admission, china, CIQ, compliance, contents, declaration, facility, FDA, FDCA, federal, Food drug and Cosmetic act, foreign, GMP, good manufacturing practice, health, import refusal, inspection, labeling, manufacturer, net quantity, origin, Quarantine, regulatory, report, united states, violation

FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public … READ MORE

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