FDA 483 OBSERVATION · #439 OF 1,000 MOST-CITED
HACCP plan - not validated
FDA cited this observation 44 times across 38 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
You did not validate that your HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way.
You did not validate that your HACCP plan is adequate to control food hazards at least annually.
You did not validate that your HACCP plan is adequate to control food hazards when a change in the process occurred that could have affected the hazard analysis or altered the HACCP plan in any way.
You did not validate that your HACCP plan is adequate to control food hazards at least once within 12 months after implementation.
You did not validate that your HACCP plan is adequate to control food hazards at least annually.
You did not validate that your HACCP plan is adequate to control food hazards at least annually.
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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