FDAImports.com Welcomes New Administration and Marketing Manager and Digital Communications Strategist
FDAImports.com recently welcomed two new staff members to its growing team. FDAImports.com recently hired Anne Lehan as the firm's Administration and Marketing Manager. Her role will be to oversee the financial, administrative and marketing functions of the...
CDER’s Restructuring will Likely Reduce FDA Transparency and Create Delays for Drug Importers
FDA’s Center for Drug Evaluation and Research (“CDER”) is establishing a new office, which in part will focus on drug importations. This move highlights CDER's increased involvement in determining the compliance of individual drug-shipments imported into the United...
FDA Clarifies its Concerns about Medical Devices from Japan
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...
FDA Steps Up Its Presence in China by Inspecting More Food Facilities
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...
FDA Makes Database of Compliance Violators Available To Public
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...
Food And Drug Safety Concerns After Natural Disasters: Joplin Tornados, Japan Tsunami and More
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...
Former FDA Regulatory Counsel Helps Japanese Exporters Know What To Expect In Post-Tsunami Setting
Benjamin L. England, a former 17-year veteran of the FDA and former Regulatory Counsel, posted a video today offering his insights into what Japanese exporters should expect in the coming months as they attempt to export products to the United States after the recent...
What Importers and Exporters Should Learn From The German E. Coli Outbreak
Benjamin L. England, former FDA Regulatory Counsel and CEO of FDAImports.com, commented on the recent E. coli outbreak in Germany. The E. coli outbreak attributed to Spanish cucumbers bears the comment that any grower or packer of fresh fruits and vegetables shipping...
Regulatory Compliance Training Sessions in Beijing and Shanghai, China
Following the two day FDLI conference, U.S.-China Food and Drug Law, in June 2011, FDAImports.com and ExporttoUSA.com.cn will provide three additional training opportunities FREE in Beijing on June 15, 2011 and in Shanghai on June 17, 2011. These sessions will give...
Benjamin England to Present at the FDLI US-China Food and Drug Law Conference in June 2011
The FDAImports.com and ExporttoUSA.com.cn team is eagerly preparing for the Food and Drug Law Institute (FDLI) US-China Food and Drug Law Conference. This conference, taking place in Beijing, China on June 13 and 14 2011, will bring expert thinkers and top...