FDAImports.com Founder and CEO, Benjamin England, will present on FDA’s PREDICT system and issues affecting the distribution and importation of cosmetic, drug and combination products from an FDA regulatory perspective at this year’s 2012 Cosmetic Science Symposium in...
Law & Regulatory
New Medical Device Identification System: Speak Now Or Forever Hold Your Peace
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...
U.S. Port Shutdown Will Disrupt Not Only Holiday Goods but Also Supply Chain Compliance, Deadlines and Costs, According to FDAImports.com
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...
Benjamin England on The Knife and Fork Show, Episode 2: China’s Food Safety Reputation
Benjamin England, Founder and CEO of FDAImports.com, on China's food safety reputation. This is part 2/3 of a video interview series on Food Chemical News' Knife and Fork Show. Part 1: Food Safety & Imports Part 2: China's Food Safety Reputation Part 3: Food...
Benjamin England to Present FSMA Seminar to Baltimore Customs Brokers and Forwarders Association in Baltimore, MD
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...
Just How Broke Could Food Manufacturers Be Next Year? FSMA Reinspection Fees for FY 2013 Give Us A Hint
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...
FDAImports.com and J.O. Alvarez, Inc. to Host Free Food Safety Modernization Act Trainings in Mexico, October 2012
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...
Countdown to October 1, 2012: New FSMA Biennial FDA Registration for All Food Facilities
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...
FDAImports.com Assists Companies with Prop 65, Safe Cosmetics Act and California Compliance and Litigation Defense in New Irvine, California Office
In addition to its corporate headquarters near Baltimore, Maryland, FDA consulting firm, FDAImports.com has opened another office in Irvine, California in an effort to assist current and future clients with the challenges stemming from California’s unique regulatory...
New Legislation Imposes Document Reviews, Risk-Based Drug Inspections and Increased Drug Listing & Drug Registration Requirements
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...