FDA 483 OBSERVATION · #775 OF 1,000 MOST-CITED
HACCP plan - monitoring procedures - none listed
FDA cited this observation 20 times across 18 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.
How FDA worded it — real examples
Your HACCP plan does not list the procedures for monitoring and frequency of monitoring at each critical control point to ensure compliance with the critical limits.
Your HACCP plan does not list the procedures for monitoring at each critical control point to ensure compliance with the critical limits.
Your HACCP plan does not list the procedures for monitoring and frequency of monitoring at each critical control point to ensure compliance with the critical limits.
Your HACCP plan does not list the procedures for monitoring and frequency of monitoring at each critical control point to ensure compliance with the critical limits.
Your HACCP plan does not list the procedures for monitoring and frequency of monitoring at each critical control point to ensure compliance with the critical limits.
Your HACCP plan does not list the procedures for monitoring and frequency of monitoring at each critical control point to ensure compliance with the critical limits.
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.
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