FDA 483 OBSERVATION · #23 OF 1,923 MOST-CITED
Critical control points
FDA cited this observation 821 times across 759 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.
The HACCP plan did not correctly identify the critical control points — the steps where control can be applied and is essential to prevent, eliminate, or reduce a hazard to an acceptable level — or set adequate critical limits at them.
Why FDA writes it — CCPs are where the hazard is actually controlled. If the wrong step is chosen as a CCP, or a critical limit is set that does not control the hazard, the plan monitors the wrong thing and the hazard passes through uncontrolled.
- Identify the critical control points for each significant hazard, based on where control is essential and achievable.
- Set critical limits at each CCP that are scientifically validated to control the hazard, and define how conformance is measured.
- Ensure each CCP has defined monitoring, corrective actions, and verification so control is demonstrable.
- Revalidate CCPs and critical limits when the hazard, process, or product changes.
- CCPs chosen by convention or convenience rather than by where the hazard can actually be controlled.
- Critical limits set to what the process produces instead of to what the science shows controls the hazard.
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 1.1× the rate of the average FDA-cited firm (8.4% vs 7.8%), across 759 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
Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
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 →