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FDA Import Holds: How to Win Releases and Fight Holds and Refusals

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August 2011
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As the FDA implements its new computerized import-screening tool called PREDICT, drug- and devicemakers are warily anticipating how it will affect the entry of their products into the U.S.

Clearly, some manufacturers will benefit by getting expedited releases ... but others will face dramatic slowdowns.

Now you can learn the ins and outs of how the new FDA processes will work, so you can be better prepared to pass through customs — without holds or inspection.

This management report is designed to address your specific concerns about PREDICT and the FDA import processes — and show you how to prepare to successfully get your imported products through customs as quickly as possible.

Here’s just a sample of what you’ll learn about the key issues:

  • How the FDA ranks imports to select which ones are sampled — and how this is changing
  • The steps companies can take to maximize their chances of not being held for further inspection
  • How to challenge an import hold and/or refusal, and what you can do to smooth out this process
  • When the FDA will choose to pursue liquidated damages, and how you can avoid them
  • How the FDA's authority over imports is changing, and how it is likely to change in the near future
  • And more.

You’ll also get answers from a leading expert to some of the most frequently asked questions from industry about imports:

  • Do you need a registration listing or foreign site registration to import materials?
  • If you own a foreign manufacturing site, which location is the importer of record – domestic or foreign?
  • Must importers register with the FDA?
  • When the FDA requests the listing number for medical devices on import, are they after the listing numbers from the foreign manufacturer’s registration? or from that of the US importer?
  • What do you do when 510(k) premarket notification has been transferred, but the 510(k) database still shows the original clearance with the old company?
  • If a shipment is placed on hold, should you expect the next shipment of the same product to be placed on hold as well?
  • Does the FDA hold notice say whether the hold is linked to an appearance, or for other reasons?
  • How do you get off the Red List (the FDA’s list of problem firms)?
  • If you know a particular port of entry is hard to work with, is it OK to switch to another?
  • Can you move shipments when the item is on hold, or does it depend on the port?
  • If an imported product is used as a medical device in the country of origin, may it be imported into the US as a nonmedical device?
  • Who is most responsible for complying with FDA regulations — the importer of record or the exporter?

Finally, FDA Import Holds gives you actual “working tools” — model documents to help you better understand how the FDA approaches import investigations, including:

  • Sample import refusal letter
  • Sample import hold letter
  • Regulatory procedures for interacting with FDA
  • Import inspection procedures used by FDA

No importing company can avoid an FDA import inspection or a screening that could lead to closer inspection or sampling. But every savvy drug- and devicemaker can — and should — understand the FDA’s processes and how they are changing as PREDICT takes hold.

Don’t expose your company to unnecessary holds, impoundments, warning letters — or worse.

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