FDA 483 OBSERVATION · #42 OF 1,923 MOST-CITED
Case history records- inadequate or inadequate
FDA cited this observation 559 times across 543 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 prepare or maintain adequate case histories — the records that document all observations and data pertinent to the investigation for each trial subject, including case report forms and supporting source documents.
Why FDA writes it — Case histories are the primary evidence that a trial subject was treated per protocol and that the reported data are real and traceable. Inadequate case histories undermine both subject-safety oversight and the integrity of the data supporting a marketing application — a core Bioresearch Monitoring finding.
- Prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation for each subject.
- Include case report forms and supporting source documents (e.g., signed consent, medical records) that allow the study to be reconstructed.
- Ensure records are attributable, contemporaneous, legible, and retained for the required period.
- Reconcile case report forms against source data so discrepancies are found and resolved.
- Source documentation incomplete or missing, so case report form entries cannot be verified.
- Records completed after the fact, breaking contemporaneity and traceability.
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 0.8× the rate of the average FDA-cited firm (5.9% vs 7.8%), across 543 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
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation and informed consent.
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation and informed consent.
Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.
Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.
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 →