FDA 483 OBSERVATION · #507 OF 1,932 MOST-CITED
Plumbing design, installation, maintenance
FDA cited this observation 48 times across 45 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 grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
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 7.8%), across 45 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. Open the 483 observation explorer →