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Preview: Recent enforcement. This is the page subscribers use. The counts and charts are the FDA record; the tables that name each recipient, and the links into the record, are for subscribers. See plans × Close preview

This is the page subscribers use. The counts and charts are the FDA record; the tables that name each recipient, and the links into the record, are for subscribers.

Preview of Clinical Precedent (Recent enforcement). This is the page subscribers use. The counts and charts are the FDA record; the tables that name each recipient, and the links into the record, are for subscribers.

Enforcement record

Recent enforcement

Warning letters and OAI classifications as FDA records them — plus what the record shows about how often an OAI inspection has been followed by a warning letter, and how long after.

Warning letters and serious inspections, year by year

Two measures on two charts, over the same fiscal years. A warning letter can follow triggers other than an OAI inspection, so the two need not move together. Hover over (or tap) any year for the count.

Warning letters issued
Serious (OAI) inspections

From OAI inspection to warning letter

Computing…

Recent warning letters

Recent serious (OAI) inspections

Recent disqualification & debarment actions

The rarest and most serious actions FDA takes against a clinical investigator — a handful per year across the whole industry. Each name links to the full list entry.

Disqualification proceedings and the debarment list →

Reading these numbers: everything here is FDA’s own record, limited in this release to drug and biologic trials. Warning-letter actions go back to FY2009, and a warning letter can also follow adverse-event reporting or an inadequate response to a 483, not only an OAI inspection. When a site you are vetting has a recent OAI, ask for its responses and corrective action plans.
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.