FDA 483 OBSERVATION · #7 OF 1,923 MOST-CITED
Sanitary operations - Plant maintenance
FDA cited this observation 1,490 times across 1,304 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 buildings, fixtures, and physical facilities of a food plant were not maintained in a clean and sanitary condition and in good repair, to prevent food from becoming adulterated.
Why FDA writes it — A plant that is not maintained in sanitary condition and good repair becomes a contamination source in itself — deteriorating surfaces, leaks, and harborage points let filth and microorganisms reach food. FDA cites plant maintenance because the physical facility is a front-line food-safety control.
- Maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition and in good repair.
- Clean and sanitise utensils and equipment as necessary to protect against contamination.
- Repair deteriorating surfaces, leaks, and structural gaps that create contamination or harborage.
- Document maintenance and sanitation so the sanitary state is demonstrable.
- Deferred maintenance that lets surfaces and structures deteriorate to a non-cleanable state.
- No documented maintenance/sanitation schedule, so lapses are invisible until an inspection.
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× the rate of the average FDA-cited firm (7.4% vs 7.8%), across 1,304 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
You did not maintain your plant in a clean and sanitary condition.
You did not maintain your plant in a clean and sanitary condition and in adequate repair.
You did not maintain your plant in adequate repair.
You did not maintain your plant in a clean and sanitary condition and in adequate repair.
You did not maintain your plant in adequate repair.
You did not maintain your plant in a clean and sanitary condition.
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 →