FDA 483 Citations Under 21 CFR 117.35: Pests, Cleaning and Sanitation

23 hours ago

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Sanitary operations are the most cited area of FDA's food current good manufacturing practice rule. In fiscal year 2025, FDA investigators cited 21 CFR 117.35 on system-generated Form FDA 483s more than 750 times across these observations:

"You did not [exclude pests from your food plant] [use pesticides under precautions and restrictions] to protect against contamination of food," 117.35(c), 249 times, the most cited Part 117 observation
"You did not maintain your plant [in a clean and sanitary condition] [in adequate repair]," 117.35(a), 211 times
"You did not clean and sanitize your utensils or equipment in a manner that protects against [allergen cross-contact] [contamination]," 117.35(a), 113 times
"You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against [allergen cross-contact] [contamination of food]," 117.35(d), 105 times
"You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use," 117.35(b)(1), 44 times
"You did not clean your non-food contact surface in a manner and as frequently as necessary to protect against [allergen cross-contact] [contamination]," 117.35(e), 43 times

These are basic requirements, and investigators can usually see the problem with their own eyes. That makes them easy to cite and hard to argue with.

What the citations mean

Investigators typically describe conditions such as:

Rodent droppings, live or dead insects, or birds in production or storage areas
Gaps under doors, open windows or unsealed openings that let pests in
Pesticides applied in or near exposed food, or by people without the required precautions
Peeling paint, damaged ceilings, condensation or standing water over production areas
Equipment with visible food residue after cleaning
Cleaning frequencies that allow buildup between runs, or no cleaning between allergen changeovers
Unlabeled chemicals, or sanitizers used at concentrations no one verified

What 21 CFR 117.35 requires

Part 117, Subpart B, sets current good manufacturing practice for human food. Section 117.35 covers sanitary operations:

General maintenance (117.35(a)): buildings, fixtures and other physical facilities must be maintained in a clean and sanitary condition and kept in repair adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces or food-packaging materials.
Cleaning and sanitizing substances and toxic materials (117.35(b)): cleaning compounds and sanitizing agents must be free from undesirable microorganisms and safe and adequate under the conditions of use. Toxic materials must be identified, held and stored in a manner that protects against contamination of food, food-contact surfaces or food-packaging materials.
Pest control (117.35(c)): pests must not be allowed in any area of a food plant, with limited exceptions such as guard or guide dogs where unlikely to cause contamination. Effective measures must be taken to exclude pests from manufacturing, processing, packing and holding areas and to protect against contamination of food on the premises by pests. Pesticides may be used only under precautions and restrictions that protect against contamination.
Sanitation of food-contact surfaces (117.35(d)): all food-contact surfaces, including utensils and equipment, must be cleaned as frequently as necessary to protect against allergen cross-contact and contamination of food.
Sanitation of non-food-contact surfaces (117.35(e)): non-food-contact surfaces must be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and contamination.

For facilities subject to the preventive controls requirements in Subpart C, sanitation may also be a preventive control under 21 CFR 117.135(c)(3), for example for environmental pathogens in ready-to-eat food exposed to the environment. Sanitation citations can therefore lead to questions about the food safety plan.

How to respond to the 483

FDA does not set a single deadline for responding to a food 483, but most firms respond in writing within 15 business days, which gives FDA the response before it decides whether to take further action, such as a warning letter.

Correct the conditions immediately

Fix every condition the investigator saw: clean, repair, seal openings, remove pests and evidence of pests, and dispose of or evaluate any food that may have been contaminated. Take dated photographs and keep work orders as evidence.

Evaluate affected product

Decide whether any food made, packed or held under the cited conditions may be adulterated. Document the evaluation and the disposition. If adulterated food may have shipped, consider whether a recall is needed.

Fix the sanitation system

A written pest control program, with a licensed provider where appropriate, a device map, service records, trend review and corrective action thresholds
A master sanitation schedule listing every area, piece of equipment and surface, with method, frequency, chemical, concentration and responsibility
Written cleaning procedures for each piece of equipment, including allergen changeover cleaning
Pre-operational inspection and verification, such as visual checks, ATP swabbing or allergen testing as appropriate
Chemical control: approved list, labeling, storage away from food and concentration checks
A facility maintenance program with inspection and repair tracking

Train and verify

Train sanitation crews, production staff and supervisors. Schedule internal GMP inspections of the facility at a set frequency and record the results.

What a compliant sanitation program contains

Master sanitation schedule
Equipment and area cleaning procedures
Allergen changeover cleaning and verification
Pest control program and records
Chemical approval, storage and concentration verification
Facility and equipment maintenance
Pre-operational and periodic inspections
Environmental monitoring where required by the food safety plan
Corrective actions and records
Training

Common mistakes in sanitation responses

Cleaning for the inspection but not changing the schedule that let buildup happen
Relying on a pest control contractor without reviewing their reports or trends
Writing one generic cleaning procedure for every piece of equipment
Never verifying sanitizer concentration
Fixing the building but not deciding what happened to product made in the meantime

Example: how one response section might read

This illustrates structure only; your response must describe your own facility and facts.

Observation 1: You did not exclude pests from your food plant. Specifically, rodent droppings were observed on pallets of packaged product in the warehouse.

Response:

Correction: The warehouse was cleaned and sanitized, affected pallets were evaluated and product with any exposure was destroyed on a stated date. Photos and destruction records are attached.
Root cause: A damaged dock door seal and gaps around a utility penetration allowed entry, and pest control service reports showing rising activity were not reviewed.
Corrective action: Door seals were replaced and openings sealed. The pest control program was revised to require monthly trend review, action thresholds and a written response to each service report.
Verification: The facility will perform documented weekly exclusion inspections for three months, then monthly.
Training: Warehouse and sanitation staff were trained on pest evidence and reporting.

Frequently asked questions

Is our pest control contractor responsible for the citation?

No. The facility is responsible for excluding pests. A contractor helps, but you must review their findings, act on trends and keep the building sealed.

Do we need written sanitation procedures under Part 117?

Subpart B describes required conditions rather than mandating written procedures for every task, but written procedures and records are the most practical way to show compliance. If sanitation is a preventive control under Subpart C, written procedures and records are required.

How often should equipment be cleaned?

As frequently as necessary to protect against allergen cross-contact and contamination. The frequency should come from your products, processes and verification results, not a fixed habit.

How A.P. Lyon documents help

A.P. Lyon's food safety documents include a Pest Control Procedure, a Cleaning and Sanitation Procedure, an Allergen Management Procedure and a Premises, Hygienic Design and Zoning Procedure. They are written for ISO 22000, FSSC 22000 and FDA 21 CFR 117, and they are also available within the full food safety management system.

Documents are editable Word and Excel files and must be adapted to your facility, products and equipment. Staff must be trained and the programs followed. A.P. Lyon does not provide food safety consulting or facility inspections.

Next steps

Correct every cited condition and document it with photos and records
Evaluate and disposition any affected food
Put a master sanitation schedule, pest program and chemical controls in place
Respond in writing within 15 business days with dates for each action

To build a complete set of procedures at a volume discount, use Build Your QMS.

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