FDA 483 OBSERVATION · #102 OF 1,923 MOST-CITED
Verification activity frequency
FDA cited this observation 290 times across 275 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 you to establish and follow an appropriate frequency for each supplier verification activity; this citation means the frequency is undefined, unjustified, or too infrequent to keep confirming the foreign supplier controls the hazard.
Why FDA writes it — FDA cites frequency gaps because a verification activity performed once, or on an arbitrary interval, cannot catch a supplier that degrades between checks — the interval itself is what turns verification into ongoing assurance rather than a snapshot.
- Set an activity-by-activity frequency and document the risk-based rationale — hazard severity, supplier history, and the strength of the control.
- Follow the schedule and record each occurrence with its date and outcome.
- Shorten the interval after adverse findings or supplier changes, and record why the frequency was adjusted.
- Defaulting to an annual cadence for every supplier regardless of hazard severity or performance.
- No documented basis for the chosen interval, so it cannot be defended as appropriate.
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 (9.8% vs 7.8%), across 275 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 document the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
You did not document the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
You did not determine and document the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
You did not document the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
You did not determine and document the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
You did not document the frequency of conducting the verification activities to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
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 →