FDA Suspends Foreign Inspections, Takes Measures to Ensure Import Safety
© , Sandler, Travis & Rosenberg, P.A. Originally published in the [03/12/2020] issue of the Sandler, Travis & Rosenberg Trade Report. Reprinted by permission.
The Food and Drug Administration has announced that it is postponing most foreign inspections through April in response to the COVID-19 outbreak. Foreign inspections deemed mission-critical will still be considered on a case-by-case basis.
For more information, please contact FDA consultant Domenic Veneziano at (202) 734-3939.
In the meantime, the FDA will employ additional tools to ensure the safety of regulated products imported into the U.S. These include denying entry of products that fail sample testing or violate other applicable legal requirements, physical examinations and/or product sampling at U.S. borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records in advance of or in lieu of on-site drug inspections.
The FDA will also continue working with U.S. Customs and Border Protection to target products intended for importation that violate applicable legal requirements for FDA-regulated products. These may come from a variety of sources, the FDA states, including first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law, and the FDA’s PREDICT risk-based import screening tool continues to adjust risk scores as necessary during the outbreak. The FDA is also monitoring carefully for indications of port shopping or cargo diversion and will continue its oversight of shipments through potentially higher-risk venues such as international mail facilities.