How to Prevent Insanitary Storage Violations in Food Facilities

A recent FDA enforcement action against a wholesale food distributor offers a clear look at what happens when basic storage and segregation controls break down — and what any food facility can do to prevent the same outcome.

FDA warning letters for insanitary conditions rarely come as a surprise to anyone who has walked the warehouse floor. The problems that generate them — chemical products stored alongside food, inadequate pest controls, poor temperature management, no documented inspection protocol — tend to accumulate slowly. One shortcut leads to another, and before anyone names it as a problem, the conditions are embedded enough that employees treat them as normal.

In March 2026, FDA issued a warning letter to JZ Wholesale, Inc., a food distribution operation, citing violations under 21 CFR Part 117 for conditions that rendered food adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Among the findings: toilet bowl cleaner stored on the floor in proximity to dietary supplements, lemongrass tea, and juice. The full warning letter is available on FDA's website.

I'm not going to dwell on that company. What I want to do is use this as a concrete example of a pattern I see repeatedly — and talk through what actually prevents it.

What the Regulations Require

The core requirement isn't complicated. Under 21 CFR Part 117, Subpart B (Current Good Manufacturing Practice), food facilities are required to take all reasonable measures and precautions to ensure that the facility, equipment, and utensils used for manufacturing, processing, packing, or holding food do not become a source of contamination.

Specifically, 21 CFR §117.20(b) addresses plant construction and design — requiring that facilities be maintained in a clean and sanitary condition and that they be kept in repair sufficient to prevent food from becoming adulterated. 21 CFR §117.35 covers sanitation operations, and 21 CFR §117.80 extends these requirements to manufacturing and storage operations broadly.

For facilities that also handle dietary supplements, 21 CFR Part 111 adds another layer — including requirements for physical separation of dietary supplements from other products and substances that could cause contamination.

The adulteration standard itself comes from Section 402(a)(4) of the FD&C Act, which deems a food adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Note the word "may" — FDA does not need to prove actual contamination occurred. Proximity to a contamination risk is sufficient.

That last point is one that food facility operators frequently underestimate. By the time an inspector finds a chemical near a food product, the legal threshold for adulteration has already been crossed.

Why These Violations Keep Happening

In my experience working with food distributors and manufacturers, insanitary storage violations almost never result from malicious intent. They happen because of three recurring gaps.

The first gap is the absence of a written hazard-based storage plan. Many smaller distributors receive products and store them based on available space rather than product compatibility. Without a documented plan that explicitly prohibits co-location of chemicals with food products, employees make individual judgment calls — and those calls are inconsistent.

The second gap is inspection frequency. A facility that conducts documented walk-through inspections daily, or at minimum weekly, catches drift before it becomes a pattern. Facilities without a scheduled inspection protocol only identify problems when an FDA investigator walks in. By that point, the window to self-correct has closed.

The third gap is training that doesn't reach the people making storage decisions. Training records at many facilities show completion of a general food safety course. What they don't show is whether the person receiving a pallet of cleaning products at 6 a.m. understood that those products cannot be staged near the dietary supplement shelf — even temporarily. Temporary becomes permanent faster than anyone plans.

The Control Systems That Prevent This

What would have prevented a warning letter in this type of case? In my view, it comes down to four interconnected controls.

A Documented Storage Segregation Policy

This is the foundation. The policy needs to name specific categories of incompatible products — cleaning chemicals, pesticides, lubricants, sanitizers — and specify the physical separation requirements. "Keep chemicals away from food" is not sufficient. The policy needs to define distances or dedicated zones, address floor storage explicitly (since that is where violations tend to concentrate), and assign responsibility for enforcing it.

The policy should be reviewed and signed off annually at minimum, and whenever the facility's product mix changes significantly.

A Hazard Analysis That Covers Storage Conditions

Under the Preventive Controls for Human Food rule (21 CFR Part 117, Subpart C), covered facilities are required to conduct a hazard analysis that identifies hazards requiring a preventive control. Chemical contamination from co-mingled storage is a recognized hazard. If it doesn't appear in your hazard analysis, your FSMA-required Food Safety Plan has a gap.

Many facilities I review treat the hazard analysis as a one-time exercise completed at registration and never revisited. Under 21 CFR §117.170, the Food Safety Plan must be reanalyzed at least every three years — and whenever a significant change occurs that could reasonably affect whether a new hazard has been introduced or a previously identified hazard is no longer being adequately controlled.

A static Food Safety Plan is not a compliant one.

Scheduled Environmental and Storage Inspections

Documented, scheduled inspections are one of the most straightforward controls available to a food facility, and they're consistently underutilized. The inspection checklist should specifically address:

• Physical separation of food from non-food chemicals
• Floor storage of any products (food or non-food)
• Condition of containers (no damaged or unlabeled chemical containers near food)
• Pest evidence (droppings, gnaw marks, entry points)
• Temperature and humidity conditions where applicable
• General sanitation of storage areas

Inspection records should be retained and reviewed by management. Not because FDA will necessarily ask for them during every inspection — but because a pattern of documented, signed-off inspections demonstrates that a facility has a functioning sanitation monitoring system, which matters enormously when FDA does show up and finds a problem.

Employee Training Tied to Specific Procedures

Training that names specific prohibited practices — "cleaning chemicals may not be stored on the floor of, or adjacent to, any aisle or zone designated for food or dietary supplement storage" — is more effective than general food safety orientation. The training should be documented, the documentation should show what was covered, and there should be a mechanism for refresher training when a new product category enters the facility.

For facilities handling dietary supplements alongside general food products, I'd argue this training needs to address the 21 CFR Part 111 requirements specifically, because the segregation standard for dietary supplements carries its own regulatory weight beyond Part 117.

A Comparison: Compliant vs. At-Risk Storage Practices

What FDA Is Looking For During an Inspection

FDA investigators conducting a CGMP inspection of a food storage or distribution facility are going to walk the floor. They're going to look at what's stored near what. They're going to ask for your Food Safety Plan and your sanitation records. They're going to want to see evidence that inspections have been conducted and that findings were addressed.

What tends to create the most significant warning letter findings is a combination of: visible, obvious conditions (chemicals near food is about as visible as it gets) and the absence of documentation showing those conditions are monitored and managed. The first issue gives them the violation. The second issue gives them the inference that the violation is systemic rather than incidental.

If you have a documented inspection from three days before the FDA visit that shows the storage area was checked and found in compliance, that changes the conversation — even if the current finding is real. It suggests a breakdown in an otherwise functioning system, rather than no system at all.

Practical Compliance Steps You Can Take Now

If you operate a food distribution or storage facility and you haven't reviewed your storage practices recently, here's where to start.

This week: Walk your warehouse floor and identify every non-food product — cleaners, sanitizers, lubricants, pest control materials — and confirm each one is stored in a physically separated zone with clear labeling. If anything is currently staged near food, move it before you do anything else.

Within 30 days: Review your Food Safety Plan. Does your hazard analysis address chemical contamination from storage practices? Does it have a documented preventive control? If not, that's a gap that needs to close. Under 21 CFR §117.165, monitoring of preventive controls needs to be documented — if chemical segregation is a preventive control, there needs to be a monitoring record.

Within 60 days: Establish or refresh a documented storage inspection procedure. Assign it to a named role, set a frequency, and create a checklist that inspectors sign and date. Pull those records into your records management system.

Within 90 days: Conduct refresher training for anyone involved in receiving, staging, or storing products. Document what was covered, not just that training occurred.

These aren't complicated interventions. They're the kind of controls that FDA's CGMP regulations have required for years, and the kind that — when they're actually functioning — keep a facility off the enforcement docket.

One More Thing Worth Naming

There's a pattern I've noticed across facilities that receive warning letters for insanitary conditions: they tend to be facilities where the person responsible for food safety is also responsible for four other things. Operations, purchasing, scheduling, compliance — all assigned to one person who's doing their best but doesn't have the bandwidth to run a functioning inspection program on top of everything else.

That's not a failure of intent. It's a resource allocation problem. And FDA, reasonably, doesn't grade on that curve. The regulations apply regardless of staff size or budget, and the legal threshold — "may have been rendered injurious to health" — is low enough that proximity alone can establish a violation.

If your compliance function is under-resourced, the most practical thing I can tell you is: start with the controls that are cheapest to implement and hardest to miss. Documented daily inspections cost almost nothing. A written storage segregation policy costs almost nothing. Those two things alone would have changed the story in a significant number of warning letters I've reviewed.

About the Author

Jared Clark, JD, MBA, PMP, CMQ-OE, CQA, CPGP, RAC is the Principal Consultant at Certify Consulting. He has served 200+ clients across food, dietary supplement, pharmaceutical, and medical device sectors, with a 100% first-time audit pass rate over 8+ years of consulting practice. For questions about food facility CGMP compliance or FDA inspection readiness, contact Certify Consulting directly.

For related guidance, see our resources on FDA inspection readiness for food facilities and building a compliant Food Safety Plan under 21 CFR Part 117.

Last updated: 2026-04-24