FDA 483 OBSERVATION · #159 OF 1,923 MOST-CITED
Drip and condensate
FDA cited this observation 196 times across 193 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 adequate protection against contamination of food, food-contact surfaces, and packaging by drip or condensate from fixtures, ducts, pipes, and ceilings. Overhead condensation was allowed to drip onto exposed product or equipment.
Why FDA writes it — Condensate that drips from overhead surfaces carries whatever has accumulated there — mold, dust, and microbial contamination — directly onto exposed food and food-contact surfaces, a classic and preventable route for pathogens like Listeria to reach product.
- Design and maintain ventilation to control humidity and minimize condensation on overhead surfaces.
- Insulate or reroute pipes and ducts, and slope or shield surfaces so condensate cannot drip onto product zones.
- Do not run exposed-product lines beneath uncontrolled overhead condensation; relocate or protect the line.
- Inspect overhead areas routinely for drip and condensate and correct sources before production.
- Ventilation and humidity control were never balanced to the plant load, so condensation forms on cold overhead surfaces.
- Overhead inspection is not part of the pre-operational sanitation check, so drip goes unnoticed until product is exposed.
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 1.3× the rate of the average FDA-cited firm (10.4% vs 7.8%), across 193 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 prevent drip and condensate from contaminating food-contact surfaces.
The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces and food-packaging materials.
The plant is not constructed in such a manner as to prevent drip from contaminating food-packaging materials.
The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces and food-packaging materials.
The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food and food-packaging materials.
The plant is not constructed in such a manner as to prevent condensate from contaminating food and food-contact surfaces.
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 →