The U.S. Food and Drug Administration (FDA) has extended the registration renewal deadline for medical device establishments from Dec. 31, 2012 to Jan. 31, 2013. In addition, FDA has been drastically overloaded and delayed in responding to communications from the extra MDUFA III requirements this year and is asking industry to allow two weeks for responses. FDA is also rolling out a new online registration and listing platform.

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The Food and Drug Administration Safety and Innovation Act (FDASIA), passed in July 2012, is intended to help increase … READ MORE

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 Hungry for more?  Enjoy our 2011 holiday campaign, “Santa vs. FDA”

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FDAImports.com Founder and CEO, Benjamin England, presented 2 half-day training sessions in Monterrey and Celaya, Mexico on compliance with the U.S. Food Safety Modernization Act (FSMA) for Mexican food producers and manufacturers.  The training sessions, in conjunction with U.S. Customhouse Broker, J.O. Alvarez, Inc., outlined the most important and relevant FSMA provisions, the FDA’s current implementation status, how to prepare for anticipated regulations followed by a lengthy and vigorous question and answer session.

“The FSMA training sessions in Celaya and Monterrey were a huge success,” … READ MORE

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Customs brokers and importers who act as U.S. Agents on behalf of their foreign food manufacturing suppliers now face a new financial risk under the Food Safety Modernization Act.  Before FSMA there was no such thing as an inspection fee for a foreign facility that might become subject to a reinspection.  Now, FDA reinspections will incur a $289/hour (foreign reinspection fee) charge from FDA. FDA expects to use these charges to generate $25 million per year in … READ MORE

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Our friends at Food Chemical News are rolling out a brand-new conference this December – A conference solely aimed at addressing Food Safety Modernization Act issues relevant to food imports.  Ben England, Founder and CEO of FDAImports.com, will be presenting on Day 1 of the conference in a session entitled, “Quantifying Added Costs of Operating Under New Regulation Standards.”  This particular presentation will cover FSMA fees, production process cost changes under FSMA and added time/resource expenditure for … READ MORE

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Benjamin England, Founder and CEO of FDA consulting firm, FDAImports.com, will present a half-day seminar on the Food Safety Modernization Act to the Baltimore Customs Brokers and Forwarders Association (bcbfa.org) in Baltimore, MD.

The seminar will address:

• The current status of FSMA and the overall implementation timeline
• Why FSMA is experiencing so many delays
• FSMA and the impact on supply chains
• The FSMA “Time Bombs” and how to prepare for them
• The hidden costs in FSMA that will be paid by the industry

The seminar will be held on September 19, 2012 at the Best Western Hotel and Conference Center in Baltimore, MD.

• 5625 … READ MORE
  
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The U.S. Food and Drug Administration recently released its Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for FY 2013.  Under FSMA FDA has the authority to assess and collect fees to cover reinspection-related costs and costs associated with non-compliance with a food recall order.  So just how much are we talking about?

• $221 per hour where domestic travel is required

• $289 per hour where foreign travel required.

That doesn’t sound too bad, right?  Think again. Though FDA explains each factor and details the … READ MORE

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FDAImports.com, in partnership with U.S. Customhouse Broker, J.O. Alvarez, Inc., will be hosting two Food Safety Modernization Act training sessions in Celaya and Monterrey, Mexico this October 16th and 18th respectively (free of charge).  The training sessions will be presented by former FDA Regulatory Counsel and current FDAImports.com Founder & CEO, Benjamin England, and will provide clear and customized FSMA training for Mexican and South American food producers and manufacturers who are looking to understand the impact that new and … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, recently spoke at the Food and Drug Law Institute’s Annual Conference on the Food Safety Modernization Act and imports.  During the presentation, “How FSMA Changed the Game on Imports,” Mr. England discussed, along with leading FDA lawyers and industry and FDA officials, elements related to FSMA affecting imported foods and international trade, including the Foreign Supplier Verification Program (FSVP), the Voluntary Qualified Importer Program (VQIP), various challenges to the international supply … READ MORE

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FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap between budget and its ever-increasing responsibilities. As the agency attempts to launch new procedures and regulations in coming years, a primary source of funding will be from user fees, according to the justification set forth.  It’s not that FDA is unfamiliar with user fees … READ MORE

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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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