Imports

FDA Wants Your Comments!

FDA may be having some trouble with its regulations.gov website, but it still wants to hear from industry on proposed rules.  FDA had extended the comment period for the FSMA proposed rules for produce safety and preventive controls for human foods to November 15th,...

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Is Your Device Subject to UDI Regulations?

On September 24, 2013, FDA passed the Final Rule for Unique Device Identifiers (UDI).  With some exceptions, the regulation mandates that all medical devices must bear a UDI, which must be issued by FDA or an FDA-accredited issuing agency.  FDA or the accredited...

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FDA Shutdown’s Effect on Food Safety: None.

In recent discussions, Ben England, Founder and CEO of FDAImports.com said: "This shutdown will be felt by the trade, but it will not impact food safety.  As a general rule, FDA compliance officers are considered essential. Food recall coordinators are usually...

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FDA Registration Renewal – It’s That Time Again

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...

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What is “Inconspicuous” Labeling?

Did you know that FDA might take a ruler to measure your label and check if your type size matches their labeling specification?  “Inconspicuous labeling” ranks number 4 among the most frequently used labeling charges in refused food entries. FDA cares about labeling...

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