FDA 483 OBSERVATION · #6 OF 1,923 MOST-CITED
Pest control
FDA cited this observation 1,542 times across 1,345 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.
Pests were present in a food plant, or the firm did not take effective measures to exclude pests from the facility and protect against contamination of food, food-contact surfaces, and packaging.
Why FDA writes it — Pests are a visible, direct contamination vector and evidence of a breakdown in facility control. FDA cites both the presence of pests and the absence of an effective program to exclude them.
- Take effective measures to exclude pests from manufacturing, processing, packing, and holding areas and to protect against contamination.
- Maintain the building and grounds — seal entry points, manage waste and standing water, and remove harborage — so pests have no route in and no reason to stay.
- Run and document a pest-control program (monitoring devices, inspections, and, where used, pesticides applied under precautions that prevent food contamination).
- Act on and record pest sightings, treating them as a signal to find and close the entry point, not just to remove the pest.
- Reliance on treatment (traps, spraying) without fixing the structural gaps that let pests in.
- Sightings handled informally with no record or root-cause follow-up, so the same harborage recurs.
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 (8.0% vs 7.8%), across 1,345 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 exclude pests from your food plant to protect against contamination of food.
You did not exclude pests from your food plant to protect against contamination of food.
You did not exclude pests from your food plant to protect against contamination of food.
You did not exclude pests from your food plant to protect against contamination of food.
You did not exclude pests from your food plant to protect against contamination of food.
You did not exclude pests from your food plant to protect against 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 →