FDA 483 OBSERVATION · #111 OF 1,923 MOST-CITED
Training of employees and records
FDA cited this observation 269 times across 250 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 everyone engaged in manufacturing, processing, packing, or holding be qualified through a combination of education, training, or experience to perform their assigned duties, and that the required training be documented in records.
Why FDA writes it — FDA cites this when employees handling food or food-contact surfaces have no documented training in food hygiene and safety, because untrained staff are a direct route to contamination, allergen cross-contact, and unsanitary practices.
- Provide role-appropriate training in the principles of food hygiene and food safety, including employee health and personal hygiene, on hire and periodically.
- Match training and qualification to each person’s assigned duties, including supervisors overseeing controls.
- Keep dated training records identifying the person, the topic, and the trainer, and retain them for FDA review.
- Onboarding staff into food-handling roles without formal, documented food-safety training.
- Training happens verbally on the floor but is never recorded, so compliance cannot be demonstrated.
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 1.9× the rate of the average FDA-cited firm (14.4% vs 7.8%), across 250 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 train employees in the principles of food hygiene and food safety and have records documenting training of qualified individuals.
You did not train employees in the principles of food hygiene and food safety and have records documenting training of qualified individuals.
You did not train employees in the principles of food hygiene and food safety and have records documenting training of qualified individuals.
You did not train employees in the principles of food hygiene and food safety and have records documenting training of qualified individuals.
You did not train employees in the principles of food hygiene and food safety.
You did not have records documenting training of qualified individuals.
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 →