FDA 483 OBSERVATION · #522 OF 1,000 MOST-CITED
Plumbing design, installation, maintenance
FDA cited this observation 36 times across 35 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× the rate of the average FDA-cited firm (0.0% vs 8.3%), across 35 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
Plumbing is not maintained so as to prevent contamination of the water supply, food and food utensils.
Plumbing is not maintained so as to prevent contamination of the water supply.
Plumbing is not designed, installed and maintained so as to prevent contamination of the water supply, food and food utensils.
Plumbing is not maintained so as to prevent contamination of the water supply.
Plumbing is not maintained so as to prevent contamination of the water supply.
Plumbing is not maintained so as to prevent contamination of the water supply.
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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