Whose Imports Are Being Shredded at the Border?

FDA is working to tighten U.S. borders when it comes to product safety. In February alone, import alerts for “Detention Without Physical Examination (DWPE)” have been issued for several medical device or drug-like items: unapproved new drugs, active pharmaceutical ingredients that appear to be misbranded, potentially defective medical gloves, devices that appear to be without approved PMAs or IDEs or without a 510k, and even bovine amniotic fluid from countries affected by foot-and-mouth disease. If you’ve got the time, peruse through FDA’s list for a snapshot of imports held at the border.

In February, FDA officially launched its new risk-assessment tool to ensure import safety, PREDICT. The web-based database-scouring system employs product codes to help FDA inspectors determine risk based on manufacturer, country of origin, recall history, and potential security risks. PREDICT will replace the admissibility screening function of OASIS, FDA’s legacy system. According to FDA, PREDICT “will assist entry reviewers in targeting higher-risk shipments for examination.” To learn more, click here.

It is unclear whether any of the above-listed items were detained through use of the new system. But according to a video on FDA’s site, inspectors at the Port of Los Angeles (reportedly the largest in the United States) have actually been using PREDICT for several months. Many products have already been destroyed at the border, reports the video.

Could your imports be flagged by PREDICT? Are you importing items from flagged countries of origin, or have any of your international vendors come under scrutiny?

Some imports could see faster trips across the border, but “only if accurate and complete data are provided by importers and entry filers,” FDA advises.

“We expect PREDICT to offer two major benefits to FDA import inspectors, to importers, and to the public,” explained FDA Commissioner Dr. Margaret Hamburg at a presentation before the Center for Strategic and International Studies on February 4. “First, the system will automatically flag potentially risky shipments. Second, the system will give lower risk scores to more innocuous materials, which can then be cleared through FDA inspection rapidly. This allows FDA inspectors to spend their time looking at the highest-risk items. It also means that carefully labeled products with good histories will be held up for shorter periods, which is better for everyone.”

Judging from the FAQs on FDA’s site, there are still several outstanding challenges. But it appears that product labeling and coding will be pretty essential to smooth importing.

Daphne Allen