FDA 483 Citations for Warehousing and Distribution Under 21 CFR 117.93

22 hours ago

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"You did not store or transport food under conditions that protect against [allergen cross-contact] [contamination] [deterioration]." FDA investigators cited 21 CFR 117.93 with that wording 71 times on system-generated Form FDA 483s in fiscal year 2025.

Food is still at risk after it is made. In warehouses and trucks it can be stored next to chemicals, chewed by rodents, held too warm, crushed or exposed to leaking product. This citation reaches distributors, third-party warehouses and cold storage operators as well as manufacturers.

What the citation means

Examples written after "Specifically" usually describe:

Food stored next to cleaning chemicals, pesticides or non-food items
Rodent droppings, gnawed packaging or insects in storage areas
Damaged or leaking containers left with intact product
Refrigerated or frozen food held above its required temperature, with no monitoring
Allergen-containing products leaking onto other products
Food stored directly on the floor or against walls, preventing cleaning and pest inspection
No first-expired, first-out rotation, with expired product in stock
Trucks or trailers dirty, damaged or not pre-cooled before loading
Returned or damaged product mixed with saleable stock

What 21 CFR 117.93 requires

Warehousing and distribution (117.93). Storage and transportation of food must be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological) and physical contamination of food, as well as against deterioration of the food and the container.

Other sections support this:

Raw materials (117.80(b)) must be stored under conditions that protect against allergen cross-contact, contamination and deterioration
Temperature control (117.80(c)) requires food that can support rapid growth of undesirable microorganisms to be held at temperatures that prevent adulteration
Cold storage (117.40(e)) must have a temperature-indicating, measuring or recording device
Pest control (117.35(c)) requires pests to be excluded from all areas of the plant, including storage
Toxic materials (117.35(b)) must be identified, held and stored in a manner that protects against contamination of food

Sanitary transportation. The Sanitary Transportation of Human and Animal Food rule, 21 CFR Part 1 Subpart O, separately requires shippers, loaders, carriers and receivers to use vehicles and equipment that are adequately cleanable and maintained, to provide temperature control where needed for safety, to prevent cross-contact and contamination during transport, and to keep written procedures, training and records for those practices.

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 assess product

Move chemicals away from food, remove damaged and contaminated product, clean affected areas and call the pest control provider where needed. Evaluate exposed product and record its disposition.

Set storage rules

Separation of food from chemicals and non-food items
Allergen segregation and spill handling
Off-floor and off-wall storage with inspection aisles
Temperature limits and continuous monitoring for refrigerated and frozen areas, with alarms and excursion handling
Stock rotation and expiry control
Status areas for released, held, rejected and returned product
Handling of damaged goods

Control transportation

Inspect trucks and containers before loading, pre-cool refrigerated units, record temperatures during transport where safety requires it, and agree on sanitary transportation responsibilities with carriers in writing.

Train and verify

Train warehouse and shipping staff. Inspect storage areas on a schedule and review temperature records.

What compliant warehousing and distribution controls contain

Storage layout and segregation
Temperature monitoring and excursion handling
Pest control in storage
Chemical storage away from food
Stock rotation and expiry control
Damaged, returned and held product handling
Vehicle inspection and sanitary transportation procedures
Carrier agreements
Training and records

Common mistakes in warehousing responses

Cleaning up the area seen without changing storage rules
Monitoring cooler temperatures without alarms or excursion handling
Leaving third-party warehouses outside the program
Forgetting sanitary transportation responsibilities with carriers
Mixing returned or damaged goods with saleable stock

Example: how one response section might read

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

Observation 6: You did not store food under conditions that protect against contamination. Specifically, pallets of flour were stored beside pallets of floor cleaner, and rodent droppings were seen on flour bags.

Response:

Product action: The 18 affected pallets of flour were rejected and destroyed on a stated date.
Correction: Chemicals were moved to a dedicated, labeled chemical room. The pest control provider added bait stations and sealed two door gaps.
Corrective action: A storage procedure now requires chemical segregation, 18-inch wall clearance and weekly storage inspections.
Training: Warehouse staff were trained on stated dates.
Verification: The warehouse supervisor records weekly inspections, and quality reviews pest trend reports monthly.

Frequently asked questions

Does 117.93 apply to warehouses that only store packaged food?

Yes, Part 117 good manufacturing practices apply to facilities that hold food. Warehouses that store only unexposed packaged food are exempt from preventive controls but still subject to Subpart B, with modified requirements under 117.206 for packaged food that needs temperature control for safety.

Are we responsible for the carrier?

Under the sanitary transportation rule, shippers, loaders, carriers and receivers each have defined responsibilities. Agreements should state who does what.

How should we handle a cooler temperature excursion?

Record the time and temperature, evaluate the product based on how long it was out of range and how sensitive it is, decide on disposition, and fix the cause.

How A.P. Lyon documents help

A.P. Lyon's Storage, Transport and Sanitary Transportation Procedure covers storage conditions, temperature monitoring, vehicle inspection and carrier responsibilities. The Chemical Control Procedure and the Pest Control Procedure cover the related controls. 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 products. A.P. Lyon does not provide food safety consulting or facility inspections.

Next steps

Correct the conditions seen and assess affected product
Set storage, temperature and segregation rules
Control vehicles and carrier responsibilities
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.