FDA 483 Citations for Equipment and Utensils Under 21 CFR 117.40

22 hours ago

5 min read

FDA investigators cited 21 CFR 117.40 120 times on system-generated Form FDA 483s in fiscal year 2025 for plant equipment and utensils that were not designed and constructed to be adequately cleanable, or were not adequately maintained.

Equipment that cannot be cleaned becomes a home for Listeria, Salmonella and allergens. Investigators look closely at worn belts, cracked plastic, rusty frames, taped repairs, hollow rollers and wooden tools, because these are places where residue builds up and cleaning cannot reach.

What the citation means

Examples written after "Specifically" usually describe:

Cracked, pitted or worn food-contact surfaces, such as cutting boards, conveyor belts and plastic bins
Rust, peeling paint or corrosion on equipment over exposed food
Temporary repairs with tape, wire, cardboard or plastic wrap
Wooden utensils or pallets in contact with exposed food
Hollow or poorly sealed parts where residue collects
Rough welds and seams on food-contact surfaces
Equipment placed too close to walls or floors to clean around it
Cold storage units with no working thermometer
Compressed air used on food with no filtration

What 21 CFR 117.40 requires

Design, material and maintenance (117.40(a)). All plant equipment and utensils used in manufacturing, processing, packing or holding food must be so designed and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact and contamination. Equipment and utensils must be designed, constructed and used appropriately to avoid the adulteration of food with lubricants, fuel, metal fragments, contaminated water or any other contaminants. Equipment must be installed and maintained so as to facilitate the cleaning and maintenance of the equipment and of adjacent spaces. Food-contact surfaces must be corrosion-resistant when in contact with food, made of nontoxic materials, designed to withstand the environment of their intended use and the action of food and, if applicable, cleaning compounds, sanitizing agents and cleaning procedures, and maintained to protect food from allergen cross-contact and contamination.

Seams (117.40(b)). Seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt and organic matter.

Non-food-contact equipment (117.40(c)). Equipment in areas where food is manufactured, processed, packed or held, and that does not come into contact with food, must be constructed so that it can be kept in a clean and sanitary condition.

Holding, conveying and manufacturing systems (117.40(d)). These systems, including gravimetric, pneumatic, closed and automated systems, must be of a design and construction that enables them to be maintained in an appropriate sanitary condition.

Cold storage (117.40(e)). Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms must be fitted with an indicating thermometer, temperature-measuring device or temperature-recording device installed to show the temperature accurately within the compartment.

Instruments and controls (117.40(f)). Instruments and controls used for measuring, regulating or recording temperatures, pH, acidity, water activity or other conditions that control or prevent the growth of undesirable microorganisms must be accurate and precise, and adequately maintained, and adequate in number for their designated uses.

Compressed air and gases (117.40(g)). Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives.

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, so FDA has the response before it decides on further action.

Repair or replace what was cited

Replace damaged food-contact surfaces, remove temporary repairs, and repair or replace corroded equipment. Evaluate any food that may have been affected and record the disposition.

Inspect all equipment

Walk the plant with a checklist covering food-contact surface condition, seams and welds, hollow parts, temporary repairs, corrosion, clearance for cleaning, thermometers and compressed air. Rank findings by risk and set dates.

Control new equipment

Require sanitary design review before new or modified equipment is bought or installed. Food-contact materials should be suitable for food and for your cleaning chemicals.

Maintain it

Add equipment condition checks to preventive maintenance and pre-operational inspections. Ban temporary repairs, or allow them only with quality approval and a fixed date for a permanent repair. Calibrate thermometers and other instruments.

What a compliant equipment program contains

Equipment inventory
Sanitary design requirements for new equipment
Food-contact material requirements
Preventive maintenance and condition checks
Temporary repair rules
Thermometers in cold storage and calibration of instruments
Compressed air filtration and testing
Records of inspections and repairs

Common mistakes in equipment responses

Replacing the one item cited and leaving similar items in service
Allowing tape and wire repairs to continue under another name
Buying replacement parts that are no more cleanable than the originals
Forgetting compressed air and cold storage thermometers
Treating maintenance and sanitation as separate problems with no handoff

Example: how one response section might read

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

Observation 3: Your equipment is not designed to be adequately cleanable. Specifically, the conveyor belt on the slicing line is frayed and cracked, with food residue in the cracks after cleaning.

Response:

Correction: The belt was replaced on a stated date with a food-grade belt suited to the sanitation chemicals used. Product from the line on the day of the inspection was held and tested before release.
Extended review: A plant-wide equipment inspection found 14 additional items needing repair or replacement. All will be complete by a stated date, highest risk first.
Corrective action: Pre-operational inspections now include a check of food-contact surface condition, and preventive maintenance includes belt inspection every month.
Purchasing: New equipment now requires a sanitary design review before purchase.

Frequently asked questions

Are wooden utensils allowed?

Part 117 does not ban wood by name, but food-contact surfaces must be adequately cleanable and maintained. Wood is hard to clean and is often cited. Use it only where you can show it is cleanable and in good condition.

Do we need a thermometer in every cooler?

Each freezer and cold storage compartment holding food capable of supporting microbial growth must have a temperature-indicating, measuring or recording device.

Does compressed air need testing?

Compressed air that contacts food or food-contact surfaces must be treated to prevent contamination. Filtration and periodic testing are common ways to show it.

How A.P. Lyon documents help

A.P. Lyon's Preventive Maintenance and Equipment Management Procedure covers equipment design review, maintenance, temporary repairs and condition checks. The Calibration of Monitoring and Measuring Equipment Procedure and the Water, Air and Utilities Quality Procedure cover instruments and compressed air. All are also available within the full food safety management system.

Documents are editable Word and Excel files and must be adapted to your facility and equipment. A.P. Lyon does not provide food safety consulting or facility inspections.

Next steps

Repair or replace the equipment cited and assess affected food
Inspect all equipment and fix findings by risk
Control new equipment design and temporary repairs
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.

Not sure where your quality system stands? Take the free QMS gap check: about 20 questions, an instant report of your gaps by clause, and the procedures that close each one.