FDA 483 OBSERVATION · #10 OF 1,923 MOST-CITED
HACCP plan implementation
FDA cited this observation 1,160 times across 923 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.
A firm required to have a HACCP plan did not implement it as written — critical control points were not monitored at the required frequency, critical limits were not met or verified, or the monitoring and corrective-action records the plan calls for were missing.
Why FDA writes it — For seafood and juice, HACCP is the mandatory framework that keeps identified hazards under control. A plan that exists on paper but is not executed provides no actual food-safety assurance — so implementation failures are cited even when the written plan is sound.
- Monitor each critical control point at the frequency the HACCP plan specifies, and record the monitoring as it happens.
- Take and document corrective action whenever a critical limit is not met, including how the affected product was controlled.
- Verify the plan is working — calibrate monitoring instruments, review records, and validate that critical limits actually control the hazard.
- Reassess the plan when the process, product, or hazard information changes.
- A validated plan on file that the floor does not follow at the required monitoring frequency.
- Records completed after the fact rather than at the moment of monitoring, so a lapse cannot be caught in time to protect product.
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 (9.1% vs 7.8%), across 923 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 implement the monitoring, recordkeeping and verification procedures listed in your HACCP plan.
You did not implement the recordkeeping and verification procedures listed in your HACCP plan.
You did not implement the monitoring, recordkeeping and verification procedures listed in your HACCP plan.
You did not implement the monitoring, recordkeeping and verification procedures listed in your HACCP plan.
You did not implement the monitoring and verification procedures listed in your HACCP plan.
You did not implement the recordkeeping procedures listed in your HACCP plan.
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 →