FDA 483 OBSERVATION · #24 OF 1,923 MOST-CITED
Record keeping
FDA cited this observation 797 times across 749 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.
Required records were not maintained, were incomplete, or were not retained, retrievable, and legible for the required period — the general recordkeeping failures that undermine the ability to reconstruct what was done.
Why FDA writes it — Records are the evidence that controls were actually applied. If records are missing, incomplete, or unretrievable, the firm cannot demonstrate compliance for any activity they should document — so recordkeeping failures both stand alone and compound every other finding.
- Maintain all required records so they are legible, retrievable, and stored to minimise deterioration and loss, for the required retention period.
- Make records available for review and copying by FDA during inspection.
- Ensure records are complete and made at the time of the activity (contemporaneous), not reconstructed.
- Control record changes with attribution, date, and reason — never obscure an original entry.
- Records completed after the fact or in batches, breaking contemporaneity.
- Poor storage/retrieval so records exist but cannot be produced during inspection — read as “no record”.
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 0.7× the rate of the average FDA-cited firm (5.5% vs 7.8%), across 749 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
You did not maintain complete and retain treatment records.
You did not maintain complete treatment records.
You did not maintain complete treatment records.
You did not maintain complete treatment records.
You did not keep treatment records.
You did not keep treatment records.
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 →