FDA Warning Letter: When Pest Control Reports Aren't Enough

What FDA Found

In a pattern documented repeatedly across multiple FDA warning letters in 2025 and 2026, FDA inspectors arrive at food facilities that have pest control programs on paper — and find evidence that those programs are not functioning as required.

The specific violations cited most frequently under 21 CFR 117.35 follow a consistent pattern:

• Rodent excreta pellets observed in food storage areas, on pallets, near packaging equipment, and in dry storage — in areas the pest control program was supposed to be monitoring
• Structural gaps — holes in interior walls, gaps near packaging equipment, unprotected utility penetrations — that provided active pest entry points
• Insanitary conditions — clutter, debris, and harborage materials stored alongside food products
• Inadequate corrective actions — pest activity observed during previous inspections with no documented evidence that root causes were addressed

What the Facility Missed

This is the gap that defines most pest-related FDA citations. The facility treated the pest control program as a service to purchase, not as a compliance system to manage. The difference matters enormously when an FDA inspector arrives.

The Regulatory Framework

Understanding what 21 CFR 117.35 actually requires is essential context for this analysis.

21 CFR 117.35(a) requires that the physical plant be maintained in a clean and sanitary condition and kept in good repair to prevent food from becoming adulterated.

21 CFR 117.35(c) specifically addresses pest control: "Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests."

The word "effective" is doing significant legal work in that sentence. FDA does not evaluate whether you have a pest control program. FDA evaluates whether your pest control program is actually working — and whether you can prove it.

PCI Analysis

The Three Documents FDA Inspectors Ask For First

Based on documented FDA inspection patterns, when an inspector arrives and finds evidence of pest activity, these are the first three documents they request:

1. The most recent three PCO service reports — specifically checking whether findings were documented, whether corrective actions were assigned, and whether those actions were verified as complete
2. The corrective action log for any pest finding from the previous 12 months — specifically checking whether root cause was documented and whether the action was closed with evidence
3. The pest monitoring device map — specifically checking whether the map is current, whether devices near the finding location were being inspected at the correct frequency

If any of those three documents are incomplete, unsigned, or show open corrective actions, the inspection trajectory changes significantly.

What FSMA Preventive Controls Requires Beyond Basic Pest Management

Facilities operating under FSMA's Preventive Controls for Human Food rule face requirements that go beyond traditional pest management documentation. Under 21 CFR 117.150, when a preventive control — which includes sanitation controls that address pest management — is found to be ineffective, the facility must:

• Identify and correct the problem
• Evaluate whether the affected food is safe
• Prevent the problem from recurring
• Document all of the above with records that are subject to FDA review

Most facilities understand the first point. Very few have robust systems for the third and fourth.

What a Compliant Facility Looks Like

A facility that would pass FDA scrutiny under 21 CFR 117.35 demonstrates the following, regardless of whether pest activity was found:

• PCO service reports are complete, signed by both technician and site contact, and filed within 48 hours of each visit
• Every finding in every service report has an assigned corrective action with a responsible party, a due date, and a closure verification
• Trend analysis is reviewed quarterly — showing activity patterns, device capture rates, and program effectiveness over time
• The pest device map is current and reflects actual device locations, not the layout from when the program was first established
• Structural conditions are inspected as part of every service visit, with documented findings and maintenance work orders for any gaps or entry points identified

The Bottom Line

FDA warning letters related to pest control share a common thread: the facility thought they were compliant because they had a pest control program. FDA cited them because the program could not demonstrate effectiveness.

The standard under 21 CFR 117.35(c) is not documentation of activity. It is evidence of effectiveness. Those are not the same thing — and the difference is where most facilities are exposed.