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...
FDAImports.com Convinces an Obstinate FDA to Remove Client from Import Alert #72-03 Red List
The www.FDAImports expert team of FDA consultants and FDA attorneys obtained removal of another client processor from another FDA Import Alert, this time, Import Alert #72-03, “Detention without Physical Examination and Intensified Coverage of Pig Ears and other Pet...
Earthquake Will Cause Importers of FDA-Regulated Products From Japan to Face New Hurdles
FDAImports, consultants and affiliated attorneys have been thinking about and praying for all of our friends, colleagues and clients affected by the massive earthquake and tsunami which struck Japan on March 11th. We wanted to provide an update on the affect of these...
Recently Published FDA Import Refusal Report May Cause Complications for Foreign Manufacturers
FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes...
FDA Food Facility Registration Requirements Change: Due to the Food Safety Modernization Act
On January 4, 2011, the Food Safety Modernization Act (FSMA) was signed into law and the U.S. Food and Drug Administration (FDA) gained significant new authorities. Among other things, the FSMA made a number of changes to FDA Food Facility Registration authority....