Increasing FDA Manual Review Rates Seen as Repercussion for Non-Compliant Filers, FDA Official Says

SAN ANTONIO -- Increasing levels of manual review for filers of Food and Drug Administration regulated goods that fail evaluations should act as a deterrent for non-compliant filers and encourage them to correct issues quickly, said Alex Lopez, director-compliance at FDA’s Division of Southwest Imports, on a panel at the National Customs Brokers & Forwarders Association of America's annual conference on April 17.

Under a scheme unveiled by FDA last year (see 1810200004), filers for which serious issues are discovered in filer evaluations will be designated “official action indicated” (OAI), with three levels of increasing consequences. At first, the filer will be put at OAI CAP-1, with manual review of 40 percent of entries. If no corrective action plan is submitted upon FDA’s request, the status of the filer is elevated to OAI CAP-2, with 60 percent manual review. Then, if FDA still doesn’t get a corrective action plan or the plan submitted does not correct the issue, the filer will move to OAI CAP-3, and with 100 percent of the filer's shipments manually reviewed, Lopez said.

A manual review rate of 40 percent may not sound like much compared to 20 years ago, but FDA is now stretched thin. Manual reviews will be put in the “when we have a chance file,” with longer wait times that could have repercussions on filers’ business, particularly for those dealing in fresh produce.

When that’s elevated to 60 percent or 80 percent, that becomes an even bigger blow, and is also a burden on FDA’s limited resources. “We don’t want you to be at 40 percent, 60 percent, 100 percent,” Lopez said. Filers “have to be responsible with what you submit to the agency, because we rely on that information to determine the admissibility of the shipment,” he said.

Given that burden on the agency from manual reviews, FDA will be quick to remove a filer from OAI once an acceptable corrective action is submitted, Lopez said. FDA will “definitely” move forward toward reducing manual review once it has assurance that the significant issues that were detected have been corrected, though the exact time frame might vary by import division. And FDA will also work with filers to find a way to avoid even 40 percent manual review, including by meeting with filers to resolve the underlying issues before an OAI designation, he said.