The FDA inspection record for clinical research.
Clinical Precedent turns FDA Bioresearch Monitoring (BIMO) data — clinical investigator, sponsor, CRO and IRB inspections, findings and warning letters — into the vetting check your quality team runs before site selection and during a trial. It also builds an inspection readiness checklist from what FDA has cited organizations like yours for.
Watch the walkthrough · 7 minutes. A narrated tour of the service: what the record shows and how to read it. Captions available.
This release covers drug and biologic clinical research: every clinical investigator, sponsor, CRO and IRB inspection FDA has recorded since 2008, with every finding FDA cited for them.
FDA inspection classification history
How every drug & biologic inspection on record was classified, fiscal year by fiscal year. FY2026* is the most recent year on record, and FDA is still posting inspections for it. Point at (or tap) a year for its numbers.
What you get with a subscription
Want to see the output first? Open the sample vet report — the dated, audit-ready snapshot a subscriber files.
API and MCP access. Screen names from your own systems, or connect your AI assistant to the record over MCP. Available to enterprise customers on request, along with organization-wide subscriptions: support@clinicalprecedent.com.
The FDA record behind clinical research, explained
Plain-language guides for sponsor, CRO and quality teams — no account needed. New to this? Start with what clinical investigator vetting covers.
Vetting and selecting a clinical investigator
- What is clinical investigator vetting? The due-diligence check on a clinical investigator’s FDA record
- Clinical investigator selection What 21 CFR 312.53 and ICH E6 require, and how sponsors do it
- Clinical investigator inspection history What it contains, and how a sponsor reads one
- Form 1572 due diligence What to check before a clinical investigator signs
- The site qualification visit What it covers, and the one thing it cannot confirm
- Sponsor responsibilities for clinical investigators The duties under 21 CFR 312.50–312.56
Inspections and what they produce
- Good Clinical Practice (GCP) basics Each principle, and the regulation FDA enforces it with
- Inside a BIMO inspection Who FDA inspects, and what the inspector examines
- What happens after a BIMO inspection The sequence, how long it takes, and who is told
- Form FDA 483 for clinical investigators The inspector’s observations, and what a 483 is not
- Clinical investigator deficiencies What FDA cites most often, and the regulation behind each
- OAI, VAI and NAI, explained The classifications, and what usually follows an OAI
- Warning letters to clinical investigators What one cites, and what a sponsor does about it
- FDA’s clinical investigator inspection lists What the CDER and CBER lists contain, and leave out
Status and enforcement
- Debarment vs. disqualification Two different mechanisms, routinely confused
- NIDPOE letters, explained How FDA opens disqualification proceedings
- NOOH letters, explained The second step: the Notice of Opportunity for Hearing
By the numbers
- FDA clinical investigator inspection statistics Inspections by year and classification, and the most cited regulations
All guides, with a fuller description of each → · News and announcements →
Every plan is the full product
The differences are seats and how you pay. Individual plans start immediately by card; teams and organizations can be invoiced against a purchase order.
Prices in US dollars; taxes are added at checkout where required. Full details, the invoice form and the billing questions: see plans.
Built and run by an engineering firm
We built Clinical Precedent because the inspection history behind a clinical site is public but scattered, and sponsors need it connected, curated, and current in one place. Its founders are a pharmaceutical industry professional with more than 40 years of experience and a senior software engineer, and it is a division of Elite Tech Media LLC, an Illinois software and simulation engineering firm established in 2008. More about who we are →
- The FDA record, assembled. Built from FDA Bioresearch Monitoring data, cross-referenced by FEI number and name. Every source is checked daily, and the record is updated whenever new FDA information is available.
- Not affiliated with FDA. Clinical Precedent is an independent product. It is not endorsed by, or connected to, the U.S. Food and Drug Administration.
- The record, not a verdict. It reports what FDA recorded; it does not rank clinical investigators, make recommendations or provide regulatory advice.
- A person answers. support@clinicalprecedent.com, usually within a business day.
Questions a quality lead asks first
What does it cost?
Individual: $249 a month or $1,999 a year for one named user, by card, with access the moment you pay. Team: $7,500 a year for up to five named users. Organization: six or more users, priced by seats and term and invoiced against a purchase order. Every plan is the full product; the differences are seats and how you pay. See plans.
What is available for free?
The free status check, the sample report, a preview of every tool on sample records, the guides and the inspection statistics. None of them needs an account. The record itself — inspections, findings, warning letters — needs a subscription.
Is there a free trial for the full product?
No. The full product needs a subscription, and the monthly plan is the way to try it. Before you pay you can run the free status check, read the sample report and open a preview of every tool on sample records.
Is there an AI assistant, and do I have to use it?
There is one, and it is optional. On the Vet page, “Ask about this record” answers your questions about a clinical investigator’s or site’s record: it answers only from that record and links the inspections, findings and warning letters it cites, so you can check them before you rely on it, and it does not rate anyone or recommend a decision. The same assistant answers questions about a single warning letter, or another FDA document such as a disqualification document, on that document’s page, quoting the passages it relies on, and about the records side by side on the Compare page, without ranking them. The Ask button at the top of every page is a separate assistant that takes you to the right tool or answers from our guides by quoting them; it does not read the record. Nothing you do is sent to an AI provider unless you ask it a question, and everything else — vetting, screening, search, watchlists and reports — works without it. The Privacy Policy says exactly what is sent.
Is Clinical Precedent affiliated with FDA?
No. It is an independent product built on publicly available FDA data. It is not endorsed by, or connected to, the U.S. Food and Drug Administration, and nothing here is an FDA determination.
Where does the data come from?
From FDA Bioresearch Monitoring records: every clinical investigator, sponsor, CRO and IRB inspection FDA has recorded since 2008 with its classification; every finding FDA cited for it — the findings cited on Form FDA 483s, in FDA’s own wording; warning letters back to 2008, with full text for most of them, including letters that no longer appear on FDA’s website; disqualification proceedings with the NIDPOE and NOOH letters where they are still available; the full debarment list, with the Federal Register order behind every debarment since 1998; and clinical investigator inspection records back to 1977. We assemble and cross-reference them into one record per clinical investigator, site, sponsor, CRO or IRB.
Is this legal or regulatory advice?
No. Clinical Precedent reports the record and is one input to your decision. It does not recommend, rank or certify anyone, and it does not replace your own qualification visit, your history with the site, or qualified regulatory counsel where the stakes are high.
How current is it?
Every source is checked daily, and the record is updated whenever new FDA information is available; the date of the latest check is shown on every page, and every exported report states the date its data is current to. FDA itself classifies an inspection weeks to months after it closes, so the newest records can be that old when they first appear. The dashboard shows the date of the newest record rather than hiding the gap.
Can my whole team use it?
Yes, with a seat for each person. An individual subscription covers one named user, so a team needs a seat per person — or an organization subscription, which covers the whole team with a seat per user and is invoiced against a purchase order on net-30 terms if you need them. Enterprise customers can also add API and MCP access, to screen from their own systems or AI tools. Team and Organization plans, and the invoice form, are on the plans page.
What does it cover, and what doesn't it?
Drug and biologic clinical research: every clinical investigator, sponsor, CRO and IRB inspection FDA has recorded since 2008, with every finding FDA cited for them, and clinical investigator inspection records back to 1977. At this time, it does not cover bioequivalence, GLP, PADE or REMS inspections, device trials or veterinary products; device data is planned for a later version. Non-U.S. regulators are not covered.
Individual plans start immediately by card — $249 a month or $1,999 a year. Teams and organizations can be invoiced against a purchase order.