FDA 483 OBSERVATION · #438 OF 1,000 MOST-CITED
Verification - reviewers qualifications
FDA cited this observation 44 times across 42 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 observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2× the rate of the average FDA-cited firm (16.7% vs 8.3%), across 42 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
The monitoring, corrective action, or verification record review was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions.
The monitoring, corrective action, or verification record review was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions.
The reassessment of your HACCP plan and monitoring, corrective action, or verification record review was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions.
The monitoring, corrective action, or verification record review was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions.
The monitoring, corrective action, or verification record review was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions.
The monitoring, corrective action, or verification record review was not done by an individual who had successfully completed training in the application of HACCP principles to fish and fishery product processing, or was otherwise qualified through job experience to perform these functions.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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