FDA 483 Citations for Plant and Grounds Under 21 CFR 117.20

22 hours ago

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FDA investigators cited the plant and grounds section of the human food current good manufacturing practice rule on system-generated Form FDA 483s in fiscal year 2025:

The plant was not [constructed] [designed] in a manner that facilitates maintenance and sanitary operations, 117.20(b), 111 times
The grounds were not kept in a condition that protects against the contamination of food, 117.20(a), 31 times

That is more than 140 citations. Buildings age, and small problems such as a dripping pipe, a gap under a door or a damaged ceiling tile become places where pests enter, water collects and Listeria grows. Investigators note these conditions because they show whether the facility is maintained as a food plant.

What the citations mean

Examples written after "Specifically" usually describe:

Condensate dripping from ceilings, pipes or cooling units onto exposed food or food-contact surfaces
Damaged walls, floors or ceilings that cannot be cleaned, such as cracked floors, holes in walls or missing ceiling tiles
Standing water on floors because of poor drainage
Gaps around doors, windows and pipe penetrations that let pests in
Doors propped open to the outside with no screening
Unprotected light bulbs or glass over exposed food
Too little space to separate operations or clean around equipment
Weeds, litter, standing water or stored equipment against the outside walls
Poor ventilation, leading to odors, condensation or mold

What 21 CFR 117.20 requires

Grounds (117.20(a)). The grounds around a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food. Methods include:

Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place or harborage for pests
Maintaining roads, yards and parking lots so that they do not constitute a source of contamination in areas where food is exposed
Adequately draining areas that may contribute to contamination of food by seepage, foot-borne filth or providing a breeding place for pests
Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination

If the plant grounds are bordered by grounds not under the operator's control, care must be exercised in the plant by inspection, extermination or other means to exclude pests, dirt and filth.

Plant construction and design (117.20(b)). The plant must be suitable in size, construction and design to facilitate maintenance and sanitary operations for food-production purposes. The plant must:

Provide adequate space for placement of equipment and storage of materials as necessary for maintenance, sanitary operations and production of safe food
Permit the taking of adequate precautions to reduce the potential for allergen cross-contact and contamination, for example by location, time, partition, air flow systems, dust control and other effective means
Be constructed so that floors, walls and ceilings may be adequately cleaned and kept clean and in good repair, so that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces or food-packaging materials, and so that aisles or working spaces are provided between equipment and walls
Provide adequate lighting in hand-washing areas, dressing and locker rooms, toilet rooms, and all areas where food is examined, manufactured, processed, packed or held, or where equipment or utensils are cleaned, and provide shatter-resistant light bulbs, fixtures, skylights or other glass over exposed food
Provide adequate ventilation or control equipment to minimize dust, odors and vapors, including steam and noxious fumes, in areas where they may cause allergen cross-contact or contamination
Provide, where necessary, adequate screening or other protection against pests

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.

Correct the conditions seen and protect food

Stop condensate from reaching food, cover or move exposed product, repair or seal damaged surfaces, and close gaps. Evaluate food that may have been affected and record the disposition. Where a permanent repair takes time, document an interim control, such as drip shields or rescheduling production away from the area.

Inspect the whole facility

Walk the plant and grounds with a checklist covering walls, floors, ceilings, drains, doors, windows, penetrations, lighting, glass, ventilation, condensation, space and the outside perimeter. Photograph and rank findings by risk.

Plan repairs

Set a repair plan with dates and owners, starting with conditions over or near exposed food. Some repairs are capital projects, so state the interim controls that will be used until they are complete.

Keep it maintained

Schedule routine facility inspections, often monthly, and feed findings into maintenance work orders. Include the outside grounds and the pest control contractor's findings.

What a compliant facility program contains

Facility and grounds inspection checklist and schedule
Condensation control
Floor, wall and ceiling maintenance
Drainage
Pest exclusion, such as door seals, screens and sealed penetrations
Glass and brittle plastic control
Lighting and ventilation
Zoning and separation of operations
Grounds maintenance
Records of inspections, repairs and interim controls

Common mistakes in plant and grounds responses

Fixing the one leak cited and missing others
Promising capital repairs with no interim protection for food
Leaving the outside perimeter out of inspections
Painting over damaged surfaces instead of repairing them
Ignoring condensation in coolers and freezers

Example: how one response section might read

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

Observation 4: The plant is not constructed in a manner that facilitates maintenance and sanitary operations. Specifically, condensate was dripping from the ceiling onto the open cheese packaging line.

Response:

Product action: Product packaged under the drip on the day of the inspection was held and destroyed.
Interim control: A drip shield was installed over the line on a stated date, and the area is checked for condensation each hour during production.
Permanent correction: The refrigeration contractor rebalanced the air handling and insulated the overhead pipes by a stated date.
Extended review: A plant-wide facility inspection found seven additional areas of condensation or damaged ceiling, each with a repair date.
Verification: Monthly facility inspections are now recorded and reviewed by the plant manager.

Frequently asked questions

Does 117.20 apply to warehouses?

Yes. Part 117 good manufacturing practices apply to facilities that manufacture, process, pack or hold food, including warehouses, unless an exemption applies.

Are glass light bulbs allowed?

Over exposed food, Part 117 requires shatter-resistant bulbs, fixtures, skylights or other glass, or other protection against breakage.

How often should we inspect the facility?

Part 117 does not set a frequency. Many plants inspect monthly, with more frequent checks for known problem areas such as condensation.

How A.P. Lyon documents help

A.P. Lyon's Premises, Hygienic Design and Zoning Procedure covers facility construction, condensation, glass, lighting and zoning. The Pest Control Procedure and the Preventive Maintenance and Equipment Management Procedure cover pest exclusion and repairs. 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. A.P. Lyon does not provide food safety consulting or facility inspections.

Next steps

Correct the conditions seen and protect food with interim controls
Inspect the whole facility and grounds
Plan repairs with dates and owners
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.