The Risks of an FDA Import Alert

The Risks of an FDA Import Alert

April 19th, 2013 // 5:28 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News
If your pharmaceutical company is ever subjected to an import alert, the costs to your firm can be huge. You can lose millions of dollars, waste time and also affect the reputation of your company.

How FDA Uses Import Alerts

An import alert is used to automatically detain products from your company and will refuse entry of them into the US. An Automatic Detention also will affect your future shipments even if they comply fully with the law. This can mean that your drug company cannot access the full US market and it can really hurt your sales.

Note that FDA does not just stop with the drug items that are noted on the FDA import alert. In addition to the automatic hold, FDA will look at and sample other products from the other manufacturers on the import alert.

One of the worst parts of an import alert, like an FDA cGMP warning letter, is the public nature of the alert. An import alert, like the warning letter, is public on FDA’s website. It is easy for your customers to see that your firm has lost access to the US market.

New FDA PREDICT System Prevents Easy Fixes

In the past, FDA-regulated companies would respond to an FDA import alert by opening a new company and just changing the company name. The idea was that FDA would think it was a different firm other than the one on the Automatic Detention Red List. This is a trick that will not work anymore with the  new PREDICT screening program. Note: If FDA catches you trying to trick them, and they are likely to with PREDICT, it can lead to worse problems. You even could have an FDA/OCI criminal investigation opened.

April 25 – How to Survive PREDICT – FDA’s New Import Screening Program

So how do you respond to an FDA import alert? Working with the agency and with importers and labs to get the release of the detained products can be complicated. FDA often orders relabeling, testing and extensive testing to prove that the detained products are not in cGMP violation. If you rely on an importer to do this complex work, it can delay things. The importer might decide that FDA is too demanding. They might miss a deadline in answering FDA. If this happens, the detained shipment is refused and will require mandatory destruction or the products being sent back. Getting a removal or an exemption from the alert means you have to give FDA a very detailed petition with all the information they require. Getting this right is key to get the alert lifted.

We think that the new authority given to FDA under the Food Safety Modernization Act will make the import alert process more complex. For example, we know that FDA has tried to start a user fee program to charge an importer for time/resources that FDA has to spend on reviewing the data on item that were detained. FDA also is talking about charging for the importer to turn in a petition. Some in the industry have challenged FDA on these moves, and FDA is backing off, for now.

The additional FSMAA requirements will mean that FDA will probably create import alerts that affect importers that don’t comply with the newly released Foreign Supplier Verification Program.

We have an upcoming Webinar on the new PREDICT system that can help to teach you how to deal with FDA import alerts.

Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:

Updated Daily – Read our latest FDA, cGMP Compliance News


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