FDA 483 OBSERVATION · #295 OF 1,000 MOST-CITED
HACCP plan - critical limits not listed or not adequate
FDA cited this observation 73 times across 67 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 observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2× the rate of the average FDA-cited firm (16.4% vs 8.3%), across 67 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 of the critical limits that must be met at each critical control point.
Your HACCP plan lists a critical limit that does not prevent, eliminate, or reduce to an acceptable level the occurrence of an identified food hazard.
Your HACCP plan does not list one or more of the critical limits that must be met at each critical control point.
Your HACCP plan does not list one or more of the critical limits that must be met at each critical control point.
Your HACCP plan lists a critical limit that does not prevent, eliminate, or reduce to an acceptable level the occurrence of an identified food hazard.
Your HACCP plan does not list one or more of the critical limits that must be met at each critical control point.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.