FDA re-posted its Import Refusal Report on its website, as we reported in March. For each refused-entry, FDA gives the manufacturer’s name and address, the importer’s product description, and FDA’s rationale for the refusal, along with other information. FDA, like...
FDAImports recently assisted a cosmetics company in correcting a labeling issue and subsequently attaining release on their detained product. FDA had detained an entry of their cosmetics because the ingredient list named a color additive based on the Color Index name...
FDAImports.com recently declared victory for two clients with many shipments of products under FDA automatic detention due to FDA Import Alerts. An Import Alert will always cause shipment delays, supply-chain risks, increased costs and budget overages, not to mention...
The Food and Drug Administration is no small government agency. In 2009 it boasted a 2.6 billion dollar budget and employed over 11,500 people spread from its suburban Maryland Headquarters to various national and international offices. The charts and data below...
FDAImports.com has obtained a copy of some very recent email correspondence sent by U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg to her employees announcing her decision to restructure the agency’s top management tier. Although she cites...
FDAImports.com Founder and CEO, Benjamin England, will be presenting at a RAPS webinar on July 20th, 2011 titled, "Imports and the FDA: Insight Into Evolving Regulations." This webinar will cover the changing landscape of FDA import...
Months ago the expert consultants at FDAImports.com petitioned the U.S. Food and Drug Administration (FDA) to remove a Chinese processor of soybeans from Import Alert # 99-08, “Detention Without Physical Examination of Processed Foods for Pesticides.” FDA’s basis to...
Last week FDAImports.com and ExportToUsa.com.cn hosted a series of free FDA regulatory training sessions in Beijing and Shanghai, China for Chinese companies exporting FDA-regulated goods to the United States. Over 70 people attended the training sessions from over...
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...
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...
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