FDA Debarment List
Overview and guidance for this database. Use SecureEPLS to screen quickly and confidently.
A public list of firms or persons debarred pursuant to sections 306(a), (b)(1) and (b)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a), (b)(1), and (b)(2)) as published in the FEDERAL
REGISTER (FR)
- Why it matters: Debarred firms or persons cannot participate in FDA‑regulated activities
(e.g., drug submissions); using them can jeopardize approvals and trigger enforcement.
- What to verify: Individual vs. firm, statutory basis (FD&C Act §306), effective dates, and
the scope of debarment (permissive vs. mandatory).
- Update cadence: Updated when Federal Register notices are issued; verify at engagement and
on a recurring basis for suppliers/CMOs.
- Compliance tips:
- Align checks with supplier qualification and quality agreements.
- Capture evidence in your Supplier Quality Management system with versioned attachments.
- Re‑verify before key filings or inspections.
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