FDA debarment screening

FDA publishes separate lists for drug product applications, drug imports, and food imports. Each publication identifies its statutory scope and separates firms from people. Review the scope that applies to the activity you are checking.

These FDA actions concern specific regulated activities. Check OIG LEIE, SAM and applicable state program sources separately when your requirements call for them.

Record the activity scope, exact names and published aliases searched, official page URL, retrieval time, and the relevant record and Federal Register notice. Verify the person or firm using the notice and other reliable identity evidence before resolving a potential match. A shared name alone does not identify the same party; FDA explicitly warns about several namesakes on its drug-application list.

Keep published combined first and middle names together when the source does not distinguish them. Retain the original spelling, term and annotation. Do not substitute an assumed NPI or infer a birth date from a name.

Use the publisher’s explicit current or expired publication status. A term ending on the calendar does not establish an exact restoration date. FDA’s expired food list includes expired and terminated actions, including orders withdrawn after conviction reversals. Preserve the action’s wording and consult its Federal Register notice.

At verification on October 4, 2026, FDA’s downloadable workbooks differed from the current HTML publications. The food workbook contained 12 records while the current page contained 10; the two other records appeared on the expired page. The drug workbooks also differed in published names. Use the current official pages and retain discrepancies for review.

No activated FDA source is reported. This guide does not establish live FDA screening coverage.

FDA activity scopes are reported separately from the federal and state Medicaid coverage baseline.

It records that the names and aliases searched did not produce a result in that FDA activity scope at that time. It does not determine eligibility for every regulated activity or healthcare program. Preserve the scope and search evidence, and seek qualified advice about the requirements applicable to your work.