FDA 483 OBSERVATION · #412 OF 1,000 MOST-CITED
All hazards not considered
FDA cited this observation 48 times across 48 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
In evaluating what food hazards are reasonably likely to occur, you did not consider unlawful pesticide residues.
In evaluating what food hazards are reasonably likely to occur, did not consider use of unapproved color or food additives.
In evaluating what food hazards are reasonably likely to occur, you did not consider natural toxins.
In evaluating what food hazards are reasonably likely to occur, you and the person who performed the evaluation for you did not consider unlawful pesticide residues.
In evaluating what food hazards are reasonably likely to occur, you did not consider chemical contamination.
In evaluating what food hazards are reasonably likely to occur, the person who performed the evaluation for you did not consider unlawful pesticide residues and use of unapproved color or food additives.
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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