FDA 483 OBSERVATION · #32 OF 1,923 MOST-CITED
Critical limits
FDA cited this observation 654 times across 574 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 set adequate critical limits at its critical control points, or the limits set were not validated to control the hazard — so monitoring the CCP would not actually assure control.
Why FDA writes it — A critical limit is the line between safe and unsafe at a control point. If it is missing, wrong, or not validated, the CCP monitors against a meaningless value and the hazard can pass through controlled-on-paper but not in reality.
- Set a critical limit at each critical control point that is scientifically validated to control the identified hazard (e.g., time/temperature for a lethality step).
- Base the limit on scientific or regulatory support, and be able to justify it.
- Define how conformance to the limit is measured and monitored.
- Revalidate critical limits when the process, product, or supporting science changes.
- Critical limits copied from a generic model without validating them for the specific process.
- Limits set to what the process happens to achieve rather than to what 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 1.7× the rate of the average FDA-cited firm (13.2% vs 7.8%), across 574 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 lists a critical limit that does not ensure control of one or more hazards.
Your HACCP plan lists a critical limit that does not ensure control of one or more hazards.
Your HACCP plan lists a critical limit that does not ensure control of one or more hazards.
Your HACCP plan lists a critical limit that does not ensure control of one or more hazards.
Your HACCP plan does not list a critical limit that ensures control of one or more hazards and lists a critical limit that does not ensure control of one or more hazards.
Your HACCP plan lists a critical limit that does not ensure control of one or more 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 →