FDA 483 OBSERVATION · #139 OF 1,923 MOST-CITED
Running water at suitable temperature
FDA cited this observation 215 times across 208 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 means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
The plant did not provide running water at a suitable temperature, and under pressure as needed, for its processing, cleaning, and employee-hygiene uses — including adequately hot water for cleaning and sanitizing equipment and for handwashing.
Why FDA writes it — Water that is not hot enough or not available where needed undermines every downstream sanitation step; effective cleaning, sanitizing, and handwashing all depend on water of the right temperature and pressure being reliably supplied at the point of use.
- Supply running water at a temperature suitable for each use, including hot water adequate for cleaning and sanitizing.
- Provide water under sufficient pressure at all points where it is needed for processing and hygiene.
- Ensure hand-washing stations deliver water at a comfortable, effective temperature to encourage proper washing.
- Verify water-heating capacity and delivery through periodic checks and maintenance of heaters and plumbing.
- Hot-water capacity was sized for a smaller operation and no longer meets peak cleaning demand.
- Plumbing or heater faults reduce temperature or pressure at remote stations, and there is no routine verification at the point of use.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.4× the rate of the average FDA-cited firm (2.9% vs 7.8%), across 208 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
Hand-washing facilities lack running water of a suitable temperature.
Hand-washing facilities lack running water of a suitable temperature.
Hand-washing facilities lack running water of a suitable temperature.
Hand-washing facilities lack running water of a suitable temperature.
Hand-washing facilities lack running water of a suitable temperature.
Hand-washing facilities lack running water of a suitable temperature.
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. Open the 483 observation explorer →