FDA 483 OBSERVATION · #54 OF 1,923 MOST-CITED
Floors, walls and ceilings
FDA cited this observation 443 times across 425 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’s floors, walls, and ceilings were not constructed or maintained so they could be adequately cleaned and kept in good repair — a specific facility-design and upkeep deficiency that enables contamination.
Why FDA writes it — Cleanable, well-maintained surfaces are a basic prerequisite for a sanitary food operation. Deteriorating or non-cleanable floors, walls, and ceilings create harborage and contamination routes that no procedure can fully offset — so FDA cites them as a facility control.
- Construct floors, walls, and ceilings so they can be adequately cleaned and kept clean and in good repair.
- Repair cracks, flaking paint, damaged surfaces, and gaps that create harborage or shed contaminants.
- Design and maintain drip/condensate control so ceilings and overhead structures do not contaminate food or surfaces.
- Include these surfaces in the documented cleaning and maintenance program.
- Surfaces allowed to deteriorate to a non-cleanable state through deferred maintenance.
- Overhead condensate and flaking structures overlooked because they are not food-contact surfaces.
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 1.2× the rate of the average FDA-cited firm (9.7% vs 7.8%), across 425 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 allow ceilings to be adequately cleaned and kept clean.
The plant is not constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair.
The plant is not constructed in such a manner as to allow floors to be kept in good repair.
The plant is not constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair.
The plant is not constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair.
The plant is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and kept in good repair.
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 →