FDA 483 Citations for Sanitary Facilities Under 21 CFR 117.37

22 hours ago

5 min read

FDA investigators cited 21 CFR 117.37 93 times on system-generated Form FDA 483s in fiscal year 2025 for plants that did not have adequate sanitary facilities and accommodations.

Sanitary facilities are the infrastructure behind clean food: safe water, plumbing that does not back up or cross-connect, working toilets, hand-washing sinks where people need them, and proper disposal of waste. When these fail, even well-trained employees cannot follow hygiene rules.

What the citation means

Examples written after "Specifically" usually describe:

Hand-washing sinks with no hot water, soap or paper towels
Hand-washing sinks blocked by equipment or used for other purposes, such as rinsing utensils
Too few hand-washing stations, or none near the production line
Toilet rooms that are dirty, in disrepair, or open directly into food areas
No backflow prevention on hoses, chemical dispensers or equipment connected to the water supply
Floor drains that back up or are not where water is discharged
Leaking plumbing over food or food-contact surfaces
Well water used with no testing
Garbage containers uncovered, overflowing or not emptied often enough

What 21 CFR 117.37 requires

Each plant must be equipped with adequate sanitary facilities and accommodations, including the following.

Water supply (117.37(a)). The water supply must be adequate for the operations intended and must be derived from an adequate source. Any water that contacts food, food-contact surfaces or food-packaging materials must be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, must be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils and food-packaging materials, or for employee sanitary facilities.

Plumbing (117.37(b)). Plumbing must be of adequate size and design, and adequately installed and maintained, to:

Carry adequate quantities of water to required locations throughout the plant
Properly convey sewage and liquid disposable waste from the plant
Avoid constituting a source of contamination to food, water supplies, equipment or utensils, or creating an unsanitary condition
Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor
Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing

Sewage disposal (117.37(c)). Sewage must be disposed of into an adequate sewerage system or through other adequate means.

Toilet facilities (117.37(d)). Each plant must provide employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a potential source of contamination of food, food-contact surfaces or food-packaging materials.

Hand-washing facilities (117.37(e)). Each plant must provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces or food-packaging materials, by providing facilities that are adequate, convenient and furnish running water at a suitable temperature.

Rubbish and offal disposal (117.37(f)). Rubbish must be so conveyed, stored and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, food-packaging materials, water supplies and ground surfaces.

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

Restore hot water and supplies at hand sinks, clear access, repair leaks, install backflow devices and clean toilet rooms. Evaluate food that may have been affected.

Survey the facilities

Check every hand-washing station for location, access, hot and cold running water, soap, single-use towels or dryers, and signage. Map water connections and confirm backflow prevention. Check drains, toilets and waste containers.

Verify water safety

For municipal water, keep the utility's annual water quality report. For well water, test at a defined frequency for coliforms and other parameters. Test backflow devices as required by local code.

Maintain and check

Add sanitary facilities to daily pre-operational checks and monthly facility inspections. Assign who restocks hand sinks and who cleans toilet rooms, and record it.

What a compliant sanitary facilities program contains

Water source and testing
Backflow prevention and testing
Plumbing and drain maintenance
Hand-washing station locations, supplies and checks
Toilet room cleaning and maintenance
Waste and rubbish handling
Daily and monthly checks with records

Common mistakes in sanitary facilities responses

Restocking soap once without assigning responsibility
Adding hand sinks far from where people work
Forgetting backflow prevention on hoses and chemical dispensers
Testing well water once and never again
Leaving outdoor waste areas out of inspections

Example: how one response section might read

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

Observation 5: Your plant did not have adequate sanitary facilities. Specifically, the only hand-washing sink in the packing room had no hot water and no paper towels, and a hose connected to the potable water supply had no backflow preventer.

Response:

Correction: The water heater was repaired and the sink restocked on the day of the inspection. A vacuum breaker was installed on the hose bib on a stated date.
Extended action: A second hand-washing station was installed at the packing line entrance. All 11 water connections were surveyed, and backflow prevention was confirmed or added.
Corrective action: Hand-washing stations and toilet rooms are now checked and restocked at the start of each shift, with a daily checklist.
Verification: The plant manager reviews the checklist weekly and backflow devices are tested annually.

Frequently asked questions

Do hand-washing sinks need hot water?

Part 117 requires running water at a suitable temperature. Warm water is generally expected for effective hand washing. Many state and local codes set a minimum.

Can toilet rooms open directly into production?

Toilet facilities must not be a potential source of contamination. Most plants use a vestibule, self-closing doors and good ventilation to separate them from food areas.

Do we need to test municipal water?

Not usually, if you keep the utility's water quality reports. Test where water is treated or stored on site, or where you use well water.

How A.P. Lyon documents help

A.P. Lyon's Water, Air and Utilities Quality Procedure covers water safety and backflow prevention. The Waste Management Procedure covers rubbish and offal, and the Personnel Hygiene and Employee Health Procedure covers hand washing. 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 evaluate affected food
Survey hand sinks, water connections, drains, toilets and waste areas
Verify water safety and backflow prevention
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.