FDA Begins New Filer Evaluation Process for Brokers
New filer evaluation processes recently announced by the Food and Drug Administration have now been adopted as standard operating procedures, and the agency’s field offices will start using them “beginning immediately,” said John Verbeten, director of FDA’s Division of Import Operations, at the National Customs Brokers & Forwarders Association of America Government Affairs Conference Sept. 24 in Washington.
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As relayed by the NCBFAA in July (see 1807030043), the new process will replace a strict 10 percent threshold of transmission errors causing failure of a review with a more flexible framework whereby errors that are more consequential for FDA admissibility decisions are given greater weight, while numerous smaller errors may not result in FDA action.
Rather than the current pass-fail framework, FDA will assign filers into one of three categories: no action indicated, meaning the filer had no real issues; voluntary action indicated, which means the filer had some issues that need to be corrected but nothing major was found; and official action indicated, for which the filer must develop a corrective action plan, Verbeten said. That last category is broken up into three levels. Corrective action plans must detail the steps that are being put into place to prevent a recurrence of the issues found during the evaluation. The plans need not be “novels” as long as they describe the problem found by FDA and what’s being done to correct it.
The new process is modeled on FDA’s current procedures for domestic facility inspections, Verbeten said. FDA will tell filers they plan to conduct the evaluation ahead of time, and where possible will conduct on-site visits. The agency will emphasize reaching the right people by paying attention to a given company’s organizational structure.
Evaluations will be closed out on-site, or if that’s not possible, by conference call so there can be a discussion of results and an opportunity for the filer to discuss the evaluator’s observations. Whereas previously the first-line evaluator decided if a filer passed or failed, under the new process the decision will be made by the evaluator’s supervisor after a review. The decision will be made even higher up if the review could result in a finding of official action indicated, Verbeten said. Decisions will take into account whether the issue is the result of a filer error or bad information from the filer’s importer client.
FDA will soon be providing an overview of the new procedures to NCBFAA leadership so it can be distributed to the trade association’s members, Verbeten said. The process will need tweaks as it's implemented, and FDA welcomes feedback from the trade community. One request the agency is already considering is for corporatewide evaluations for brokerages with multiple offices, with the entire brokerage receiving a grade of either no action, voluntary action or official action indicated. “We’re working our heads around that one,” Verbeten said.