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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What a year!  A lot of water has gone under the regulatory bridge- from the Carbendazim issue with Brazilian OJ to the “pink slime” media fiasco to FSMA and Chinese imports.  Here are our top 10 most popular blog posts from 2012 (most popular first).  Thanks to everyone for sharing, tweeting, liking and reading our content!

• Orange Juice & Fungicide Residues Infographic
• Pink Slime: 11 Facts You Don’t Know About the American Meat Supply
• FDA Cracks Down on Carbendazim in OJ but Ignores it in Other Foods
• Who Tells America What’s Safe To Eat? Pink Slime Story Sheds Light on … READ MORE
  
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The Food and Drug Administration Safety and Innovation Act (S. 3187) was signed into law by President Obama on July 9th of this year. The Act brings numerous changes for the drug and medical device industry but all of the attention so far has been on the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) provisions and user fees. But there are considerable changes in the legislation to how FDA conducts “inspections” that dramatically increases (unnecessarily) the drug … READ MORE

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The following is a letter from FDAImports.com Founder and CEO, Benjamin England:
As you may know, Diamond Pet Food Processors issued multiple product recalls over the last two months.  On April 12, only six days after Diamond’s first recall, FDA conducted a weeklong inspection of Diamond’s facilities and found numerous violations.  Finally, a few weeks ago, a law firm filed what is believed to be the first lawsuit against Diamond.  The lawsuit, filed on behalf of an infant sickened by Salmonella, explicitly cites the results of FDA’s inspection as evidence of Diamond’s negligence.  Don’t let this happen to you.

If Diamond had … READ MORE

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The FDA has “a total of about 50 full time equivalents to regulate a very large and growing industry,” said Michael Landa, Director of the Center for Food Safety and Applied Nutrition at the FDA in a statement made during a Senate hearing on the safety of cosmetics a few weeks ago. Landa went on to state that although the cosmetics industry is moving product in the billions of dollars, FDA has little more than a dozen employees that actually work in the trenches of … READ MORE

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Christmas.  Easter.  Halloween.  If it’s a holiday then Americans are spending.

A recent Journal of Commerce article, Imports Set to Surge, delivers growing import statistics and projects increased growth for coming months with the implication that retailers are building up stock for increased spending.  “Imports from Asia in January rose 2.9 percent year-over-year, and Moreno forecasts traffic growth will level out at 2.5 percent in 2012,” the article states.  Yet it seems that every time a gift-giving holiday comes around, importers are always behind in … READ MORE

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In a recently updated Q/A section on the FDA’s FSMA web page, FDA attempts to clarify the impact of FSMA upon “High-Risk” food facilities.  Essentially, FDA plans to utilize a database to identify the world’s High Risk Facilities and inspect them all every 3 years. Also FDA plans to inspect the world’s Non High-Risk facilities every 5 years.  According to FDA, there are currently 22,325 domestic facilities classified as HR. That designation was arrived at by application of the following criteria:

… 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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The FDA has recently made public and easily accessible several databases disclosing the results of FDA inspections for companies with compliance issues related to the Food, Drug and Cosmetic Act and results of criminal investigations and debarment actions along with an easy to use warning letter, untitled letter and cyber letter resource.  Although such information has always been available from FDA, it could only be obtained by a written request under the Freedom of Information Act … 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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