FDA 483 OBSERVATION · #150 OF 1,923 MOST-CITED
Storage
FDA cited this observation 204 times across 200 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
Food, ingredients, or packaging were not stored and held under conditions that protect them against contamination and deterioration — pallets on wet floors, no pest exclusion, temperature or humidity not controlled, or raw and finished goods and allergens commingled. This is the warehousing-and-distribution requirement of §117.93.
Why FDA writes it — Improper storage lets otherwise safe food become adulterated after production through pest activity, moisture, temperature abuse, or allergen cross-contact. FDA cites this because holding conditions are part of protecting food from farm to distribution, and a lapse in the warehouse undoes upstream controls.
- Store food off the floor and away from walls on clean pallets or racking, with defined spacing that allows cleaning and inspection.
- Control storage temperature and humidity for products that require it and monitor and record those conditions.
- Segregate allergens, raw materials, chemicals, and finished goods so cross-contact and chemical contamination cannot occur.
- Apply stock rotation (FEFO/FIFO) and a warehouse pest-management and sanitation program, with records to prove conditions were maintained.
- Warehouse treated as outside the food safety scope, so storage conditions were never monitored or included in sanitation.
- Space pressure leading to overstacking, floor storage, and commingling that defeats segregation and cleaning.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.2× the rate of the average FDA-cited firm (9.5% vs 7.8%), across 200 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Labels were stored such that mix-ups were possible.
Failure to store raw materials in a manner that protects against contamination.
Failure to store raw materials in a manner that protects against contamination.
Failure to store raw materials in a manner that protects against contamination.
Failure to store raw materials in a manner that protects against contamination.
Failure to store raw materials in a manner that protects against contamination.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →