In response to a request from the State of Queensland, Australia, FDAImports.com partnered with Trade and Investment Queensland to present a webinar entitled “How to Successfully Export FDA and USDA Regulated Products to the United States.”  The webinar was a fantastic success, with more than 20 companies registered after only minimal marketing.

Ben England, Founder and CEO of FDAImports.com, and Rick Quinn, Principal of FDAImports.com, presented for an hour on the US Agencies, the import process, and the regulations and pitfalls involved.  Following the presentation, there was a productive Q&A session, … READ MORE

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Rick Quinn, Principal at FDAImports.com, and Shelly Li, Regulatory Specialist of ExportToUsa.com.cn, traveled to China to visit companies listed on FDA Import Alert in March.

The team intended to increase Chinese companies’ awareness and understanding of FDA rules and regulations, as well as how to successfully export FDA-regulated products to the United States. During this trip, the team visited companies throughout  the provinces of Guangdong and Hainan. They visited industry members involved with food (mainly seafood), cosmetics, devices, etc.

Companies showed great interest in what FDAImports.com has to offer, especially in learning more about … READ MORE

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FDAImports.com recently attended and sponsored the Maryland China Business Council’s (MCBC) 18th Annual New Year Banquet at Hunan Manor restaurant in Columbia, MD.  The annual banquet provides valuable networking opportunities for many professionals, dignitaries and embassy personnel involved in US/China trade, including companies involved in FDA-regulated commodities. “It’s clear that there is significant opportunity here,” said Ben England, Founder and CEO of FDA consulting firm, FDAImports.com (ExportToUsa.com.cn in China).  Shelly Li, Regulatory Specialist in the firm’s Qingdao, China office, was also in attendance for the … READ MORE

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FDAImports.com announced recently that it would be presenting a webinar on April 15 for companies and trade professionals in the food, drug, cosmetic, homeopathic, dietary supplement, and medical and radiological device industries.  The webinar, which is called “How to Successfully Export FDA and USDA Regulated Products to the United States,” will broadly cover the regulations, requirements, issues, and pitfalls involved in importing goods to the US, before offering an open Question-and-Answer session.

Attendees will learn

• The US Agencies and what they regulate (FDA, USDA, etc.)
• FDA/USDA regulatory requirements for imported products
• The Food Safety Modernization Act: … READ MORE
  
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How much would you be willing to pay an attorney or paralegal to take care of all your FDA facility registration and product listing woes?  $500?  $750?  What about to have a reputable company serve as your US Agent, facilitating communications with FDA and making sure that your registrations and listings are up-to-date and compliant?   $1000?  Many companies are charging prices like these or higher for these services.  There seems to be a mindset in the industry that these services are hugely complex and take many hours, so they’re worth hundreds or … READ MORE

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Rick Quinn, Partner at Maryland-based FDA consulting firm, FDAImports.com, will be presenting at the third annual conference of Affiliated Lawyers of the Americas (ALTA), discussing the intersections of regulatory compliance and business law.  The conference will be held from February 28 to March 2, 2013, in Long Beach, California, and is entitled “Cross Border Business in Mexico and the Americas.”  Mr. Quinn will be discussing the unique opportunities for attorneys representing South American food, drug, cosmetic, supplement and medical device firms looking … READ MORE

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This post was contributed by FDAImports.com Regulatory Consultant, Walt Brittle

Recently, Dan Starks, CEO of St. Jude Medical, Inc., announced to the media and investors that their Sylmar plant would likely receive a Warning Letter in response to an inspection prompted by St. Jude’s 2010 recall of faulty wires used in defibrillators.  The company hoped to inform and reassure investors with the announcement that the Warning Letter was little more than FDA “exercising its role in a very vigorous and robust way.” As predicted, the plant did receive a … READ MORE

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Rick Quinn, Principal at Maryland based FDA consulting firm, FDAImports.com, will be serving as a panelist at the Natural Products Expo West Town Hall meeting for retailers, “Defining Natural Together” on Sunday, March 10th, 2013 at 9am Pacific Time.  The session, part of the Natural Products Expo West event in Anaheim, CA, is intended to provide an opportunity for attendees to work together to create a meaningful industry definition of “natural” in the absence of a functional definition from the U.S. Food and Drug Administration (FDA).  Rick Quinn will … READ MORE

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FDAImports.com has opened an office in Chennai, India, a major commercial and economic hub located in Tamil Nadu, India.  India, with significant exports of rice, wheat, sugar, seafood and other FDA-regulated products, is a major trade partner with the United States for a variety of key commodities.  In fact, India is currently leading the world in rice trade, surpassing Thailand as a 4-year ban on non-basmati rice exports comes to an end.1 “Indian companies export some of the world’s finest products to the United States,” said Rick Quinn, Principal … READ MORE

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The U.S. Food and Drug Administration recently announced its Final Rule for the Administrative Detention of Foods under the Food Safety Modernization Act (FSMA).  The rule adopts the Interim Final Rule from May 2011 without change.  With this Final Rule, FDA now has the power to administratively detain any food simply because FDA claims it has reason to believe the food is adulterated or misbranded.  You may want to read that again: FDA may now administratively detain any food that it believes to be … READ MORE

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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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<iframe width=”623″ height=”350″ src=”http://www.youtube.com/embed/6-1VPEdZF8g” frameborder=”0″ allowfullscreen></iframe>
Watch our other … READ MORE

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