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Preview: Disqualified and debarred. This is the page subscribers use. The counts are the FDA record; the lists themselves, with every proceeding and document, are for subscribers. See plans × Close preview

This is the page subscribers use. The counts are the FDA record; the lists themselves, with every proceeding and document, are for subscribers.

Preview of Clinical Precedent (Disqualified and debarred). This is the page subscribers use. The counts are the FDA record; the lists themselves, with every proceeding and document, are for subscribers.

Enforcement

Disqualified and debarred

The two FDA actions that can end a clinical investigator’s eligibility — disqualification (a regulatory proceeding that starts with a NIDPOE letter and can bar a clinical investigator from receiving investigational products) and debarment (a statutory penalty tied to criminal conviction). Every proceeding on record, its outcome, and the underlying FDA documents where available.

Disqualification proceedings

A NIDPOE (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain) opens the case; a NOOH (Notice of Opportunity for Hearing) escalates it; the status shows how it ended. Proceedings span all FDA centers — a disqualification bars the clinical investigator regardless of product type.

Clinical investigatorCenterLocationStatus Status dateNIDPOENOOHDocuments

Debarment list

Debarment under FD&C Act §306 follows a criminal conviction connected to drug products. It is a separate track from disqualification, and reaches beyond clinical investigators (pharmacists, executives, submission fraud) — but several clinical investigators appear on both lists. A person FDA has since taken off its list stays here, marked as no longer on it.

NameEffectiveTermStatusOrder
Matching caveat: these lists carry names only — no facility identifiers — so connecting a list entry to an inspection record is a name match. Same-name clinical investigators exist; confirm identity (location, specialty, dates) before acting on a match. Each clinical investigator link runs our vetting check under that name.
Clinical Precedent™ — clinical site intelligence from the FDA record Built from FDA Bioresearch Monitoring data. This release covers CDER and CBER inspections of clinical investigators, sponsors, sponsor-investigators, CROs and IRBs — drug and biologic clinical research. At this time, it does not cover bioequivalence (BEQ), Good Laboratory Practice (GLP), postmarketing adverse drug experience (PADE) or REMS inspections, device trials (CDRH) or veterinary products (CVM). The service reports the record; it does not make recommendations or provide regulatory advice. It does not cover other factors in clinical investigator selection — therapeutic-area expertise, site capabilities, your own history with the clinical investigator, enrollment track record, and your qualification visit. Sources last checked 2026-10-13 — every source is checked daily; updated whenever new FDA information is available. About · Guides · News · Pricing · Contact · Terms of Service · Privacy Policy · support@clinicalprecedent.com Clinical Precedent on YouTube, LinkedIn and X. Clinical Precedent is a division of Elite Tech Media LLC, an Illinois software and simulation engineering firm established in 2008; Clinical Precedent is its registered Illinois assumed name. Clinical Precedent™ and the shield mark are trademarks of Elite Tech Media LLC.