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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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.

Background
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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By now food manufacturers should be more than aware of the new Biennial Food Facility Registration requirement set forth under the Food Safety Modernization Act (If not, read this NOW).  Though registration is a relatively painless process, it can be time-consuming and frustrating, especially for those who registered several years ago and now must find or obtain their login credentials.

FDA has taken note of the food industry’s scramble to obtain their login credentials and complete their registrations.  FDA recently released a statement to the effect that officials may “exercise … READ MORE

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On November 26th, 2012 the U.S. Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a New Mexico producer of peanut butter and peanut products due to a “reasonable belief” that their products had sickened some consumers with a strain of Salmonella.  This marks the first time that FDA has leveraged this new enforcement authority given to it under the 2011 Food Safety Modernization Act (FSMA).  Under the FSMA, FDA can suspend the … READ MORE

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December 31st, 2012 is a crucial date for agents and owners of domestic and foreign food facilities.  It is the date by which all food facilities need to re-register with the U.S. Food and Drug Administration.  If you’re not aware of the history of this registration change or the implications of not re-registering, please read our first blog here.  The quick facts are:

• Domestic and Foreign food facilities must be registered by December 31, 2012

• Previous registrations are no longer valid.  Owners and agents must re-register

• There are many new … READ MORE
  
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It’s almost here.  The new biennial FDA registration requirement for foreign and domestic food facilities imposed by the Food Safety Modernization Act (FSMA) takes effect October 1, 2012.

FSMA amended Food, Drug and Cosmetic Act (FDCA) Section 415 by requiring foreign and domestic food producers to register their facility every two years with FDA, rather than just “one time for all time.”  What does this mean for foreign food producers that export food to the United States?  Turns out quite a lot.

Under the FDCA, … 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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Why didn’t your kids get what they wanted for Christmas?
Why didn’t your tree have candy canes on it?
What happened to your toy cosmetic kits, sunglasses, chocolates and candy?

Answer: Your stuff was all detained at a U.S. port due to:

• Candy canes having undeclared Red 40 in them.

• Chocolates from China being on import alert for melamine.

• Cosmetic kits having glitter in them which FDA suddenly thinks is a color

• Sunglasses having invalid Impact Resistance Certificates

Santa Claus was on his way to deliver these goodies to your children but was … READ MORE

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Adults, children and regulatory compliance officers alike all reeled last week at the news of Santa Nicolas Claus’ arrest by the FDA’s Office of Criminal Investigations and Immigration and Customs Enforcement.  Eyewitness cell-phone video emerged immediately following the arrest but now FDAImports.com has obtained additional footage and interviews from an amateur journalist at the scene.  The following 2 video clips provide additional details into Santa’s arrest, conversations with agents, the scene of the crime and numerous interviews with bystanders including Mr. Claus’ attorney, Benjamin England.  Mr. England stated that his firm was doing everything possible to hasten the judicial … READ MORE

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We warned him. We heard the rumors this was coming and sure enough it did.  The U.S. Food and Drug Administration’s Office of Criminal Investigations (OCI) teamed up with Homeland Security agents of Immigration and Customs Enforcement (ICE) and reportedly arrested Santa Claus tonight as he was out testing a new sleigh configuration in Columbia, MD.  Eyewitness accounts caught the whole event on video, even capturing the agents’ rough treatment of Santa (and his tears) as he was put into the FDA’s special enforcement SUV.  “I saw all this commotion down in the parking lot … READ MORE

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Santa Claus should be at the top of the U.S. Food And Drug Administration’s “naughty list” according to Benjamin England, a 17-year veteran of the FDA and Founder of FDAImports.com.  According to England Santa Claus has broken almost every rule in the book and violated numerous food, drug, facility registration and import laws, regulations and standards over the years as he has illegally imported millions of dollars worth of merchandise to children in the United States, albeit as gifts.  Since all imports coming into … READ MORE

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