FDA 483 OBSERVATION · #142 OF 1,923 MOST-CITED
Written record of investigation incomplete
FDA cited this observation 213 times across 206 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.
The written record of an investigation into an unexplained discrepancy or a batch (or its components) failing to meet specification is incomplete — it lacks the conclusions, follow-up, root cause, or the extension of the investigation to other batches and products that may have been associated with the failure, as required by §211.192.
Why FDA writes it — The investigation record is how a firm proves it understood a failure and contained it. An incomplete record means FDA cannot confirm root cause was found or that other potentially affected batches were evaluated — the risk is releasing product that shares an undiscovered defect.
- Document each discrepancy or OOS investigation with a defined scope, root-cause analysis, conclusions, and a follow-up decision.
- Explicitly assess whether other batches or products were associated with the failure and record the disposition of each.
- Justify batch disposition (release, reject, rework) on the investigation’s findings, not on a retest that overrides the original result.
- Require quality-unit review and approval of the completed investigation before final batch disposition.
- Investigations close on the first plausible cause without confirming it or extending scope to related batches.
- The template lacks required fields (conclusion, other-batch impact), so records read as complete when they are not.
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 2.4× the rate of the average FDA-cited firm (18.9% vs 7.8%), across 206 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
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
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 →