FDA 483 OBSERVATION · #143 OF 1,923 MOST-CITED
Training records
FDA cited this observation 211 times across 201 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 the training establishing an individual as qualified be documented in records, including the date of the training, the type of training, and the person trained — records that exist specifically to prove qualification.
Why FDA writes it — FDA cites missing or incomplete training records because, absent documentation, there is no way for the firm or an investigator to verify that food handlers and preventive-controls staff were ever trained — undocumented training is, for compliance purposes, no training.
- Create a training record for each session capturing the trainee, the training type, and the date.
- File records so they are retrievable during inspection and tie to the individual’s role and duties.
- Retain training records for the period the CGMP recordkeeping rules require and update them as retraining occurs.
- Training is delivered but not logged, or logs omit the date or training type needed to make them complete.
- No central, retrievable system for training records, so documentation cannot be produced on request.
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 0.8× the rate of the average FDA-cited firm (6.0% vs 7.8%), across 201 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 establish and keep records that document personnel training, including the date of training, training topics and persons trained.
You did not establish and keep records that document personnel training, including the date of training, training topics and persons trained.
You did not establish and keep records that document personnel training, including the date of training, training topics and persons trained.
You did not establish and keep records that document personnel training, including the date of training, training topics and persons trained.
You did not establish and keep records that document personnel training, including the date of training, training topics and persons trained.
You did not establish and keep records that document personnel training, including the date of training, training topics and persons trained.
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 →