FDA 483 OBSERVATION · #128 OF 1,000 MOST-CITED
Floors, walls and ceilings
FDA cited this observation 177 times across 172 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 1.3× the rate of the average FDA-cited firm (11.1% vs 8.3%), across 172 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
The plant is not constructed in such a manner as to allow ceilings to be adequately cleaned and kept clean.
The plant is not constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair.
The plant is not constructed in such a manner as to allow floors to be kept in good repair.
The plant is not constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair.
The plant is not constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair.
The plant is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and kept in good repair.
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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