FDA 483 OBSERVATION · #116 OF 1,923 MOST-CITED
Buildings/good repair
FDA cited this observation 259 times across 250 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 buildings and structures were not maintained in a clean and sanitary condition and in good repair — this covers cracked or peeling walls and ceilings, damaged floors, deteriorating surfaces, and structural defects that can shed material into food or shelter pests.
Why FDA writes it — A building in disrepair sheds paint, plaster, rust, and dust into product, and cracks and gaps admit pests and moisture; the physical fabric of the plant must itself be sound because it is in constant contact with the food environment.
- Establish a preventive maintenance program that inspects and repairs walls, ceilings, floors, and structures on a defined schedule.
- Repair cracks, flaking surfaces, water damage, and deteriorated finishes before they become a contamination source.
- Use durable, cleanable, non-shedding surface materials in food-handling areas.
- Log building conditions during sanitation inspections and track repairs to closure.
- Building upkeep is deferred as a capital cost, so deterioration is allowed to progress until an inspector flags it.
- No routine structural inspection exists — maintenance is reactive to breakdowns rather than to condition.
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 0.9× the rate of the average FDA-cited firm (6.8% vs 7.8%), across 250 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
Failure to maintain physical facilities in repair sufficient to prevent food from becoming adulterated.
Failure to maintain physical facilities in repair sufficient to prevent food from becoming adulterated.
Failure to maintain buildings in repair sufficient to prevent food from becoming adulterated.
Failure to maintain physical facilities in repair sufficient to prevent food from becoming adulterated.
Failure to maintain buildings, fixtures and physical facilities in repair sufficient to prevent food from becoming adulterated.
Failure to maintain fixtures and physical facilities in repair sufficient to prevent food from becoming adulterated.
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 →