FDAImports.com recently attended and presented at the 2014 India International Seafood Show in Chennai. Principal Rick Quinn and India Country Director Shanmugam Jayakumar met with processors, exporters, and industry members at the FDAImports.com booth, discussing the...
Rick D. Quinn, Principal of FDAImports.com, will be attending the India International Seafood Show, January 10-12, 2014, in Chennai, India, along with Mr. Shanmugam Jayakumar, FDAImports.com's India Country Director, will be exhibiting at the show for the first time...
2013 marks the third consecutive year that FDAImports.com has been showcased at the China Fisheries and Seafood Expo. This year Benjamin England, Rick Quinn, John Wu, Shelly Li, and Ge Song attended the show, November 5 to 7, 2013 in Dalian, to meet and connect with...
Look out, industry: there’s a new way to get put on Import Alert. FDA is beginning to place firms on import alert based on traceability data collected by FDA and the Center for Disease Control and Prevention (CDC). Firms used to think they would only end up on...
Myth 1: DQSA grants the FDA sweeping authority in determining what pharmacies can compound. Compounding sophisticated, difficult-to-produce drugs will not be prohibited. Traditional compounding pharmacies – those small operations which compound drugs that fill...
Benjamin England, FDAImports.com Founder and CEO, and Bill Nychis, Senior Regulatory Advisor, recently co-presented a webinar entitled “FDA Import Holds: New Powers to Control Products.” Mr. England provided an overview of FDA’s drug importation enforcement authority,...
For decades, FDA and the States’ jurisdiction over compounding were at odds. Compounding has traditionally been governed by the States, and pharmacists could supply patients with compounded drugs without needing FDA’s approval. The controversial Drug Quality and...
Whenever Customs issues a claim for liquidated damages, U.S. law gives the importer the right to petition for mitigation or cancellation of the damages amount. It is becoming increasingly difficult to persuade the government to mitigate or cancel these cases, because...
This year, FDA has published two Import Alerts to regulate unapproved veterinary drug use in imported honey. On May 23, Import Alert 36-04 published a Red List of manufacturers of honey and blended syrup whose products will be detained due to fluoroquinolones. On June...
An outbreak of fungal meningitis, traced to contamination in compounded injectable steroids, jump-started the movement to increase federal authority over compounding operations. Now, federal oversight is about to increase, with the President expected to sign into law...
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