FDA 483 OBSERVATION · #337 OF 1,000 MOST-CITED
Contamination with microorganisms, chemicals, filth, etc.
FDA cited this observation 81 times across 79 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 0.2× the rate of the average FDA-cited firm (1.3% vs 7.7%), across 79 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
Proper precautions to protect food and food-packaging materials from contamination with microorganisms cannot be taken because of deficiencies in plant design.
Proper precautions to protect food from contamination with microorganisms, filth and extraneous material cannot be taken because of deficiencies in plant construction and design.
Proper precautions to protect food-contact surfaces from contamination with microorganisms and extraneous material cannot be taken because of deficiencies in plant.
Proper precautions to protect from contamination with extraneous material cannot be taken because of deficiencies in plant construction.
Proper precautions to protect food and food-contact surfaces from contamination with filth and extraneous material cannot be taken because of deficiencies in plant construction and design.
Proper precautions to protect food and food-contact surfaces from contamination with cannot be taken because of deficiencies in plant.
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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