FDA 483 OBSERVATION · #63 OF 1,923 MOST-CITED
Buildings/sanitary
FDA cited this observation 386 times across 374 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 and structures used for food operations were not suitable in size, construction, and design to facilitate maintenance and sanitary operations — a general finding that the physical plant does not support hygienic production.
Why FDA writes it — The building envelope is the outermost food-safety control. When the plant itself is not built or maintained to permit sanitary operation, contamination becomes difficult to prevent no matter how good the procedures inside are.
- Provide buildings of suitable size, construction, and design to facilitate maintenance and sanitary operations.
- Provide adequate space for equipment and materials so operations can be performed sanitarily.
- Separate operations that could contaminate food (by location, time, partition, air flow, or other effective means).
- Maintain the building so it stays in a clean, sanitary, and good-repair condition.
- A plant whose size or layout forces incompatible operations to cross.
- Structures allowed to deteriorate so sanitary operation is no longer possible.
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 1.1× the rate of the average FDA-cited firm (8.8% vs 7.8%), across 374 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 buildings, fixtures, or other physical facilities in a sanitary condition.
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
Failure to maintain buildings, fixtures, or other physical facilities in a 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 →