FDA 483 OBSERVATION · #113 OF 1,923 MOST-CITED
Qualifications of individuals
FDA cited this observation 265 times across 251 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.
Human-food CGMP requires that each individual engaged in manufacturing, processing, packing, or holding food be a qualified individual — possessing the education, training, or experience needed to perform assigned duties, including anyone doing preventive-control tasks.
Why FDA writes it — FDA cites this when people are assigned food-safety-relevant duties they are not qualified to perform, because an unqualified individual monitoring a control or making a corrective-action decision undermines the entire food safety system.
- Define the qualifications each role requires and confirm each person meets them through education, training, or experience.
- Ensure anyone performing or overseeing preventive controls is a preventive-controls-qualified individual where the rule requires it.
- Document the basis for each individual’s qualification and keep it current with role changes.
- Assigning control-related duties by availability rather than by demonstrated qualification.
- No documented link between a role’s required competencies and the assigned person’s actual training or experience.
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 1.2× the rate of the average FDA-cited firm (9.2% vs 7.8%), across 251 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 have records documenting food hygiene and food safety training.
You did not have records documenting food hygiene and food safety training.
You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training.
You did not have records documenting food hygiene and food safety training.
You did not have records documenting food hygiene and food safety training.
You did not ensure individuals were qualified to perform their assigned duties.
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 →