FDA 483 OBSERVATION · #12 OF 1,923 MOST-CITED
FD-1572, protocol compliance
FDA cited this observation 1,016 times across 971 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
A clinical investigator did not conduct the study in accordance with the signed Statement of Investigator (Form FDA 1572) and the investigational plan — for example, deviating from the protocol, enrolling ineligible subjects, or dosing outside the approved regimen without authorization.
Why FDA writes it — By signing the 1572, the investigator commits to protect subjects and follow the protocol. Protocol non-compliance undermines both subject safety and the integrity of the data supporting a marketing application — the two things a Bioresearch Monitoring inspection exists to verify.
- Conduct the investigation in accordance with the signed 1572, the current protocol, and the investigational plan; obtain sponsor and IRB agreement before any change except to protect subject safety.
- Verify and document subject eligibility against the inclusion/exclusion criteria before enrollment.
- Record, justify, and report protocol deviations promptly — an unreported deviation is worse than the deviation itself.
- Maintain source documentation adequate to reconstruct that the study was run as the protocol specified.
- Deviations made in real time for practical reasons at the site but never documented, justified, or reported.
- Eligibility screening treated as paperwork, so ineligible subjects are enrolled and only found at monitoring.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.6× the rate of the average FDA-cited firm (4.6% vs 7.8%), across 971 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
An investigation was not conducted in accordance with the signed statement of investigator.
An investigation was not conducted in accordance with the investigational plan.
An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
An investigation was not conducted in accordance with the investigational plan.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →