FDA 483 OBSERVATION · #119 OF 1,923 MOST-CITED
Risk factors, clinical evidence
FDA cited this observation 256 times across 198 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.
In a bioresearch-monitoring inspection of a device clinical study, this observation concerns how risk factors and clinical evidence were identified, disclosed, and documented under the Investigational Device Exemption regulation. For a drug or biologic IND study the parallel investigator obligations sit under 21 CFR Part 312.
Why FDA writes it — FDA cites this when a clinical investigation understates known risk factors or lacks the clinical evidence supporting subject-safety decisions, because incomplete risk characterization exposes human subjects to hazards they were never adequately protected from or informed of.
- Ensure the investigational plan and informed consent reflect all known risk factors supported by the available clinical evidence.
- Document the clinical basis for eligibility, risk, and safety-monitoring decisions in the study records.
- Report new risk information and adverse events promptly to the sponsor and IRB as the applicable part requires.
- Risk factors and supporting evidence not kept current as the study accrues new safety data.
- Investigator records document the decision but not the clinical evidence and risk assessment behind it.
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 1.8× the rate of the average FDA-cited firm (13.6% vs 7.8%), across 198 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
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Donors were not screened by a review of relevant medical records for of communicable disease agents and diseases.
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
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 →