Is it ever legitimate for FDA to add companies to an FDA import alert without notice? No. Does FDA do this anyway? Yes, and frequently. In April 2013, many Chinese OTC drug manufacturers fell victim to FDA’s caprice. In 2012, FDA conducted a series of surprise...
Shuttered up and closed - the government shutdown was painful for many U.S. businesses. This was especially true for any business having to deal with FDA. FDA lost over 50% of its employees during the shutdown. Many of those furloughed were investigators and internal...
Did you know? If your medical device or drug facility is not registered (or renewed) by December 31, 2013, you may not be able to import products to the United States. The U.S. FDA requires any facility that handles an FDA-regulated good to register. Members of...
A recent ruling by the DC Appellate court may have drastic implications for FDA’s ability to “Release with Comment” entries that contain FDA violations. In Cook v. FDA, prisoners on death row brought suit against FDA complaining that the Agency failed to refuse...
Rick Quinn, Partner at Maryland-based international FDA consulting firm FDAImports.com, will be attending and presenting at Mindanao Exporters Congress. The show will be held at the SMX Convention Center of the SM Lanang Premier, in Davao City, Philippines, from...
At the American Association of Exporters and Importers’ recent seminar called “Partnering with OGAs on Risk Management and Globalization,” attendees discussed FDASIA, the U.S.-E.U. Mutual Recognition Agreement, and Good Importer Practices – all things one would expect...
The Food and Drug Administration Safety and Innovation Act (“FDASIA”), which was signed into law on July 9, 2012, has serious consequences for the drug industry, particularly in the import/export sector. Some of the changes upcoming from FDASIA include Increased...
Ben England and Olivia Zuniga of FDAImports.com, an international FDA consulting firm, had a fantastic experience attending and presenting at IFEX Philippines. During the exhibition, Mr. England presented two expert trainings; on the first day, he spoke to industry...
On June 10th and 11th, Ben England will be in Manila, Philippines again, providing two more days of free regulatory training for Philippine exporters of foods, beverages, dietary supplements, drugs, alternative medicines (such as homeopathic products) and cosmetics....
In response to a request from the State of Queensland, Australia, FDAImports.com partnered with Trade and Investment Queensland to present a webinar entitled “How to Successfully Export FDA and USDA Regulated Products to the United States.” The webinar was a...
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