FDA 483 OBSERVATION · #109 OF 1,923 MOST-CITED
HACCP training or qualification
FDA cited this observation 278 times across 258 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.
Seafood HACCP requires that certain functions — developing the HACCP plan, reassessing and modifying it, and reviewing monitoring records — be performed by an individual trained per the standardized curriculum or otherwise qualified through job experience. Juice processors face the parallel requirement at 21 CFR 120.13.
Why FDA writes it — FDA cites this when the person building or verifying the HACCP plan lacks documented training or equivalent qualification, because an untrained individual is far more likely to miss a hazard, set an unsound critical limit, or misread monitoring records.
- Have the HACCP plan developed and record-reviewed by an individual who has completed FDA-recognized HACCP training or can document equivalent job experience.
- Keep training certificates or an experience record on file to demonstrate the qualification.
- Ensure the qualified individual — not just any staffer — performs plan reassessment and the required record reviews.
- Assigning HACCP plan development or record review to production staff without the standardized training.
- No retained documentation of training or experience, so qualification cannot be shown even when it exists.
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 1.6× the rate of the average FDA-cited firm (12.4% vs 7.8%), across 258 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
No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.
No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.
No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.
No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.
No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.
No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.
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 →