FDA to Increase Holds for Brokers Failing New Filer Evaluations

PALM SPRINGS, Calif. -- Entry filers that fail the Food and Drug Administration’s new filer review system will see increasing levels of holds if they don’t correct issues cited by the agency, said Kevin Fritz, consumer safety officer at FDA’s Division of West Coast Imports, at the Western Cargo Conference on Oct. 19. Those that receive an “official action indicated” designation from a filer evaluation and are required to implement a corrective action plan will see manual review of 40 percent of their entries, rising to 60 percent if they fail to implement that plan and 100 percent if they fail again.

The new incremental approach replaces the old system whereby filers that failed evaluations were switched to paper filing. Other changes in the new scheme, which became operational in September (see 1809250041), include a more flexible threshold for passing or failing filers, a mandate that a responsible employee at the company be present, and a move to more on-site inspections. Filers that pass evaluations will either be designated “no action indicated,” meaning a near-perfect evaluation, or “voluntary action indicated,” for cases wherein issues don’t rise to the level at which FDA has to take action but the filer is told they should correct some problems.

Filer evaluations will be conducted once every four years, or more often if the filer got a poor result in a recent evaluation, Roger Clarke of Williams Clarke said. All filers will be notified of the pending evaluation, and be given at least 20 days to gather the information requested by FDA. In extenuating circumstances an extension would “not be a big issue,” Fritz said.

The scope of the evaluation will depend on the scale of the company’s FDA filing operations, Clarke said. Small filers that transmit 1-100 entry lines annually will have 50 lines reviewed, as will medium filers that transmit 101-1,000 lines. Large filers that transmit 1,001-10,000 lines will see 100 lines reviewed, and so will “super files” that transmit 10,001 or more entry lines annually. FDA will be reviewing disclaims, with 20 percent reviewed for small and medium filers and 40 percent for medium and large filers, Clarke said.

The basic elements being reviewed will remain the same. FDA may include in its review results some minor issues that the filer didn’t know about but were changed behind the scenes by FDA, such as incorrect product codes. FDA will also have the option to refer issues it found in remotely filed entries by another company location to the relevant geographical division office, so “they won’t penalize you for something you had nothing to do with,” Clarke said.

FDA will not only account for the role of the importer in evaluating the filer but will also proactively help the filer ensure its importers are giving them correct data. The agency offers presentations for importers at the request of their brokers to “try to paint for the importers, your clients, how the information they have impacts the information you’re able to provide,” said John Verbeten, director of FDA’s Division of Import Operations. If a broker has constant problems with data from one of its importer clients, FDA can meet with the importer and the broker to try to get the issues straightened out.

And just like with brokers, FDA can apply its approach to bad filer evaluations to importers, too. FDA may decide on more frequent holds for an importer’s shipments if it's concerned that the importer is “not providing accurate information to their filer,” Verbeten said. “There are importers who never get a system 'May Proceed' because we don’t trust” the data they give FDA, he said.