FDA 483 OBSERVATION · #88 OF 1,923 MOST-CITED
Grounds
FDA cited this observation 316 times across 289 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 grounds around the plant were not kept in a condition that protects against food contamination — this covers uncut weeds or grass that harbor pests, litter and waste, improperly stored equipment, and areas that pool water near the facility.
Why FDA writes it — Poorly maintained grounds are a reservoir for rodents, insects, and birds that migrate indoors, and standing water breeds pests and can seep into the building — the exterior is the first barrier against contamination reaching food.
- Keep grass and weeds cut and remove litter, waste, and unused equipment from the areas immediately around the plant.
- Grade, drain, and maintain the grounds so water does not pool against the building or provide a pest breeding site.
- Maintain roads, yards, and parking areas so they do not generate dust or tracked-in debris that reaches food areas.
- Document routine grounds inspections and corrective actions in the sanitation program.
- Grounds upkeep is treated as facilities landscaping rather than part of the food-safety sanitation program, so it falls outside inspection routines.
- No assigned owner or schedule for exterior weed, waste, and drainage control, so issues accumulate between formal audits.
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 1.5× the rate of the average FDA-cited firm (11.4% vs 7.8%), across 289 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 keep the grounds around your plant in a condition that would protect against the contamination of food.
You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
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 →