GAO Recommends FDA Establish Sampling Process for Seafood Imports

The Government Accountability Office (GAO) has released a recommendation that the U.S. Food and Drug Administration (FDA) establish a process that ensures the agency tests at least one shipment of imported seafood before removing it from alert status. GAO reviewed 274 removal decisions between 2011 and 2018 and found that FDA did not conduct audits for 260, or 95%, of the decisions.

“FDA officials said they conducted limited sampling because many import alert removal decisions can be supported by documentary evidence provided by firms,” GAO announced. “Additionally, for certain violations that indicate a firm failed to meet regulatory or administrative requirements and may pose a public health hazard, an FDA directive establishes a goal for FDA staff to conduct a follow-up inspection within 6 months. However, GAO’s review of removal decisions found that for 31 of the 32 firms that received such a finding, FDA did not conduct a follow-up inspection before removing them from an import alert. FDA officials said they did not know whether they were meeting their audit goals because the agency does not have a process to monitor the extent to which it is conducting its sampling and inspections. Establishing such a process would provide greater assurance that FDA is conducting its expected level of sampling and inspections to support its removal decisions and has confidence in continued compliance.”