FDA 483 OBSERVATION · #41 OF 1,000 MOST-CITED
No HACCP plan
FDA cited this observation 470 times across 436 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 do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur.
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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