FDA 483 OBSERVATION · #155 OF 1,923 MOST-CITED
As source of contamination
FDA cited this observation 199 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.
Equipment and utensils, by their design, materials, or condition, acted as a source of contamination to food — for example surfaces that could not be adequately cleaned, corroded or pitted materials, or construction with crevices that harbor residue and microorganisms.
Why FDA writes it — Equipment that cannot be effectively cleaned becomes a permanent contamination reservoir; residue trapped in seams, corrosion, or non-cleanable joints re-inoculates every batch, so the equipment itself defeats the sanitation program regardless of cleaning effort.
- Use equipment and utensils made of cleanable, corrosion-resistant, non-toxic materials suitable for food contact.
- Design and install equipment so all food-contact surfaces are accessible for cleaning, inspection, and maintenance.
- Replace or repair pitted, corroded, cracked, or worn surfaces that can no longer be adequately cleaned.
- Include equipment condition in preventive maintenance and pre-operational inspections.
- Aging equipment develops corrosion and crevices that outpace the cleaning program, and replacement is deferred.
- Equipment was selected or fabricated without hygienic-design principles, leaving surfaces that cannot be cleaned.
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 0.8× the rate of the average FDA-cited firm (6.2% 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
Plumbing constitutes a source of contamination to food, water supplies, equipment and utensils.
Plumbing constitutes a source of contamination to food, water supplies and equipment.
Plumbing constitutes a source of contamination to food, water supplies, equipment and utensils.
Plumbing constitutes a source of contamination to water supplies.
Plumbing constitutes a source of contamination to food and equipment.
Plumbing constitutes a source of contamination to food, equipment and utensils.
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 →