Tag Archives: FDA

Stricter Enforcement of FDA Food Facility Registration Requirements under the FSMA

We’ve noticed that one byproduct of the new biennial Food Facility Registration requirement is stricter enforcement of registration rules when filing Prior Notice (PN). We have seen FDA cracking down on PN filings. In particular, FDA seems to be taking … Continue reading

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FDA Biennial Food Facility Registration now AVAILABLE!

All food facilities (foreign and domestic) who have previously registered their facilities with FDA must now re-register. Under the Food Safety & Modernization Act of 2011, food facilities are now required to re-register every two years (from October 1 through … Continue reading

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Medical Device Excise Tax

A part of Obama’s Affordable Care Act included a 2.3% excise tax on medical devices. I had one importer inquire about the excise tax today and the method for paying it. Unlike the Federal excise tax on alcohol, this tax … Continue reading

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Changes to Food Facility Registration under FSMA

Food manufacturers, exporters, and importers should all be familiar with the FDA Food Facility Registration requirement. What they may not be aware of are changes to the requirement as a result of the Food Safety Modernization Act that was signed … Continue reading

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FDA- Multiple Locations and Medical Establishment Registration

Now that FDA has indicated that they will be charging importers for Establishment Registration, some importers have asked me to clarify whether they need to register each and every facility that receives goods. For example, the importer may have a … Continue reading

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