FDA 483 OBSERVATION · #586 OF 1,000 MOST-CITED
Food-contact - withstand food & cleaning cmpds.
FDA cited this observation 40 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.
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1× the rate of the average FDA-cited firm (7.9% vs 7.7%), across 38 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
Food contact surfaces are not designed to withstand the action of food and withstand cleaning compounds and sanitizing agents.
Food contact surfaces are not designed to withstand the environment of their intended use, withstand the action of food and withstand cleaning compounds and sanitizing agents.
Food contact surfaces are not designed to withstand the environment of their intended use.
Food contact surfaces are not designed to withstand the environment of their intended use.
Food contact surfaces are not designed to withstand the environment of their intended use, withstand the action of food and withstand cleaning compounds and sanitizing agents.
Food contact surfaces are not designed to withstand the environment of their intended use, withstand the action of food and withstand cleaning compounds and sanitizing agents.
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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