FDA 483 OBSERVATION · #76 OF 1,923 MOST-CITED
Verification - record review - frequency
FDA cited this observation 340 times across 304 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.
As an importer under FSVP, you must review the records a foreign supplier generates for the controls it applies to a hazard, and you must do so at a frequency that gives you real assurance the hazard stays controlled shipment after shipment.
Why FDA writes it — FDA cites this when record review is missing, sporadic, or set on a frequency that cannot detect a supplier drifting out of control — leaving a hazardous food to reach U.S. consumers before anyone notices the supplier stopped performing its control.
- Set a documented, hazard-based frequency for reviewing each supplier’s control records and justify it against the risk and the supplier’s performance history.
- Actually perform the review on schedule and keep dated records showing who reviewed what and what they found.
- Reassess the frequency when a supplier’s history, the hazard, or the results change, and tighten it if problems appear.
- Treating record review as a one-time onboarding task rather than an ongoing, scheduled verification activity.
- No written justification tying the review frequency to the specific hazard and supplier risk, so the interval defaults to whatever is convenient.
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 1.3× the rate of the average FDA-cited firm (10.2% vs 7.8%), across 304 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 review some of your critical control point monitoring records within one week after the records were made.
You did not review some of your critical control point monitoring records within one week and within a reasonable time after the records were made.
You did not review some of your critical control point monitoring records within one week after the records were made.
You did not review your critical control point monitoring and calibration records within one week and within a reasonable time after the records were made.
You did not review your critical control point monitoring records within one week and within a reasonable time after the records were made.
You did not review some of your critical control point monitoring records within one week after the records were made.
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 →