FDA Not Meeting Targets for Following Up on Import Alert Removals, GAO Says
The Food and Drug Administration is not meeting its targets for following up on importers and products removed from import alerts, the Government Accountability Office said in a report released Dec. 6. Part of that is because the agency does…
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not monitor these activities, which include audits of private laboratories and re-inspections of importers. For example, an FDA manual says the agency should audit at least one of the five non-violative private laboratory samples required for import alert removal, but out of 274 removal decisions from 2011 to 2018, FDA only audited samples from 14 of those removals, GAO said. FDA told investigators that it generally relies on firm-provided documentation to support removal decisions so it can prioritize use of limited laboratory and inspection resources. It said that checking removal decisions individually and when questions arise is sufficient, rather than regularly analyzing sampling and inspections data. But in the end, the agency agreed with GAO's recommendations and will enhance its case management system to better “document that all necessary information is present and has been evaluated to support” removal decisions. The GAO report also said FDA has still not followed up on a 2009 GAO recommendation to work more closely together with CBP on stopping evasion of import alerts.