FDA 483 OBSERVATION · #89 OF 1,923 MOST-CITED
Verification procedures - adequacy
FDA cited this observation 313 times across 282 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.
FSVP requires written procedures that ensure appropriate supplier verification activities are conducted; this observation means those procedures are missing or inadequate — they do not spell out what verification is done, by whom, or how it is judged sufficient.
Why FDA writes it — FDA cites inadequate written procedures because without them verification becomes ad hoc and unrepeatable, and neither the importer’s staff nor an investigator can confirm that the hazard-appropriate activities are reliably carried out.
- Write procedures that define, per supplier and hazard, which verification activities are performed, their frequency, and the acceptance criteria for results.
- Assign the activities to a qualified individual and require dated documentation of each one.
- Review and update the procedures whenever the hazard, supplier, or evaluation outcome changes, and keep superseded versions.
- Relying on informal practice or email instructions instead of a controlled written procedure.
- Procedures that name an activity but omit the frequency, responsibility, or acceptance criteria that make them auditable.
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 1.6× the rate of the average FDA-cited firm (12.4% vs 7.8%), across 282 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
Your HACCP plan lists verification that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Your HACCP plan lists verification procedures that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Your HACCP plan lists verification procedures that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Your HACCP plan lists verification procedures that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Your HACCP plan lists verification that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Your HACCP plan lists verification procedures and frequencies that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
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 →