FDA 483 OBSERVATION · #48 OF 1,923 MOST-CITED
Storage and Distribution
FDA cited this observation 513 times across 479 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.
Storage and distribution of food and its ingredients were not conducted under conditions that protect against contamination and deterioration — inadequate protection during holding or transport of finished product and raw materials.
Why FDA writes it — Product can be made safely and then spoiled or contaminated in storage or transit. Because storage and distribution occur after the controlled manufacturing steps, weak controls here undo the earlier ones — so FDA cites holding and distribution conditions as part of the food-safety chain.
- Store and transport food and ingredients under conditions that protect against physical, chemical, and microbial contamination and against deterioration of the food and its container.
- Control temperature and humidity where product safety or quality depends on them.
- Protect against pests and cross-contamination during holding and distribution.
- Manage stock rotation and hold/release status so unsuitable product is not distributed.
- Environmental controls (temperature, pest, cross-contamination) applied in production but not extended to storage and transport.
- No control over hold/release status in the warehouse, so product moves before it should.
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× the rate of the average FDA-cited firm (7.5% vs 7.8%), across 479 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
You did not store or transport a food under conditions that protect against contamination.
You did not store or transport a food under conditions that protect against contamination and deterioration.
You did not store or transport a food under conditions that protect against contamination and deterioration.
You did not store or transport a food under conditions that protect against contamination and deterioration.
You did not store or transport a food under conditions that protect against contamination and deterioration.
You did not store or transport a food under conditions that protect 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 →