FDAImports.com has opened a new expansion office in Manila, Philippines.  Manila is strategically located to allow FDAImports.com to handle client needs in the South Pacific – Malaysia, Indonesia, Thailand, Vietnam, and more.  The United States is one of the Philippines’ top trading partners, importing billions of dollars of machinery, apparel, and agricultural products.  “The Philippines export prime agricultural products to the United States,” said Ben England, Founder and CEO of FDAImports.com, “such as tropical oils, sugar cane, processed fruit and vegetables, tree nuts, and fruit and vegetable juices.”

“FDA’s regulatory interest in … 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 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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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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This post was contributed by FDAImports.com Senior Regulatory Advisor, Tom Knott

FDAImports.com recently saved a U.S importer of medical components the substantial cost of unnecessary laboratory testing for one of their products. When the U.S. Food and Drug Administration (FDA) found Quality System issues with the importer’s foreign manufacturer, the Agency sent that foreign facility a Warning Letter placing all of their products on Import Alert 89-04, “Detention of Devices from Firms that Have not Met Device GMPs.” Immediately FDA began to automatically detain the importer’s … 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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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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The U.S. Food and Drug Administration recently released a proposed rule that will require that most medical devices distributed in the United States carry a unique device identifier (“UDI”). A UDI is a unique code that is designed to allow anyone to identify the model number, lot or batch number, the serial number and/or expiration date for any given medical device. The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to … READ MORE

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If a labor dispute between U.S. seaport workers and port managers is not resolved before an impending September 30th deadline, then October 1 will represent more than the start of a new Federal Government Fiscal Year. It will also mark the start of a new import/export trade crisis that will make the last 12 months of U.S. economic problems pale in comparison, according to FDAImports.com. The looming shut down of many Eastern Seaboard and Gulf Coast ports will not only raise the costs of holiday merchandise but also gridlock … READ MORE

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The FDAImports.com team is pleased to welcome Steven A. Johnson to our team!  Mr. Johnson joins the firm as Principal, bringing nearly 20 years of FDA, Pharmaceutical, Biotech and Medical Device experience to the firm.  He will be assisting clients with biotech and device compliance, cGMP and GCP issues, Internet and advertising marketing compliance and in other device and pharma-related regulatory areas.  Mr. Johnson will be assisting clients from FDAImports.com’s new office in Irvine, California.  Please join us as we welcome … READ MORE

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