FDA 483 OBSERVATION · #93 OF 1,923 MOST-CITED
Harborage areas
FDA cited this observation 306 times across 291 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.
Conditions inside or around the plant provided harborage — shelter, nesting sites, or breeding grounds — for pests such as rodents, insects, or birds. This includes clutter, gaps, dead spaces, standing water, and unsealed openings that let pests establish themselves.
Why FDA writes it — Pests carry filth and pathogens directly onto food, food-contact surfaces, and packaging; eliminating harborage is the structural half of pest control, because trapping and baiting cannot keep pace with an environment that continuously shelters and breeds pests.
- Remove clutter, unused equipment, and debris that create dead spaces where pests nest, both inside and outside the plant.
- Seal wall and floor gaps, penetrations, and exterior openings; screen or close doors, windows, and vents.
- Eliminate standing water and food residue that attract and sustain pests, and store materials off the floor and away from walls.
- Have a documented integrated pest management program with defined monitoring, trending, and corrective action.
- Pest control is outsourced and reduced to placing traps, while the harborage conditions that draw pests in are never corrected.
- Storage and housekeeping practices leave clutter against walls and in corners, creating the dead spaces pests colonize.
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 1.8× the rate of the average FDA-cited firm (13.8% vs 7.8%), across 291 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 properly store equipment, remove litter and waste and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
Failure to remove litter and waste and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
Failure to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
Failure to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
Failure to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
Failure to cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
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 →