You May Not Even Know You are on Import Alert
April 8th, 2013 // 3:05 pm @ jmpickett
April 8, 2013
So your drug company has some serious cGMP guideline violations. Were you aware that FDA will not necessarily tell you if your pharmaceutical company has been placed on import alert? It happens. In some cases, an importer may have gotten the product from a third country, or from a shipper not allowed to ship into the US. In such a case, your firm may learn you are on import alert only after you ship to an authorized product distributor in the US.
Learn About PREDICT – FDA’s New Import Screening Program
Also, did you know that FDA will only accept five clean shipments in a rows to remove your drug company from automatic detention? And were you aware that many import alerts are written so that an exemption promise is often just an illusion? This all is very true, and much of these new rules are new. That’s why many drug companies are not aware of them.
Many companies don’t know they were added onto an import alert until FDA detains the first drug shipments at a US port. After learning that the shipment was held up, then the company will scramble onto the problem and work to get FDA to release the shipment.
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When your company does that, you might get a call from another customer about FDA detaining another shipment automatically. Then you are trying to get five clean shipments across the border so you can then have the customs broker provide evidence to FDA to get you removed from import alert. At that point, often FDA will reject your evidence and other importers may be tipped off to information about your other customers.
All of the above are mistakes, in our experience. You are wasting time, disclosing confidential information and you are in a weak position with FDA. In reality, getting removal or exemption from an import alert is quite a complex process, and hard to do from abroad in an efficient manner.
What To Do Then About an Import Alert?
FDA will only make a decision to remove your company or product from import alert if it receives very clear, convincing and documented data that shows that the condition that caused an apparent cGMP violation have been completely solved. The idea is for you to convince FDA to remove the product or company from import alert – but by using facts and FDA laws and regulations to make your case. Begging is never going to work! An effective petitioning process is the key to getting your product or company off import alert status.
There are many good companies that regularly help foreign manufacturers getting removal or exemption from import alerts.
On a related note, there is a new FDA system called PREDICT that has greatly changed how FDA screens drugs and devices at US ports. We have a very informative Webinar on this system coming up April 25.
