FDA suspends inspections in foreign countries due to coronavirus
The Food and Drug Administration has halted most inspections of food facilities outside of the U.S. through April, as travel restrictions increase in response to the COVID-19 outbreak.
The FDA announced the decision March 10 with a statement from Commissioner Stephan Hahn. Customs and Border Protection officers will continue to examine produce arriving at U.S. points of entry, but food safety inspections at foreign facilities are postponed until April, according to the FDA.
“Mission critical” inspections will be decided on a case-by-case basis.
The decision also affects on-site inspections at foreign drug and medical device manufacturers.
The FDA is employing interim measures, including:
Denial of imports;
- Examination and sampling of products at ports of entry;
- Reviewing a company’s compliance history;
- Using information sharing agreements with foreign governments; and
- Requesting records “in advance of or in lieu of” on-site inspection.
“The FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law,” Hahn wrote in the statement.
The FDA uses the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system for risk-based import screening to focus on high-risk imports. The agency also checks for “port shopping” or cargo diversions, according to Hahn.
The FDA continues to monitor the outbreak’s effect on operations.
“As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak,” according to Hahn’s statement.
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