FDA 483 OBSERVATION · #108 OF 1,923 MOST-CITED
Equipment, containers, utensils
FDA cited this observation 275 times across 269 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.
A dietary-supplement manufacturer’s equipment, containers, and utensils were not of appropriate design, construction, or maintenance for their use, so they could contaminate components or product or could not be adequately cleaned.
Why FDA writes it — Equipment and containers are in direct contact with the product. If they are poorly designed, made of unsuitable material, or not maintained, they become a contamination source and cannot be reliably cleaned — a direct route to adulterated dietary supplements.
- Use equipment and utensils of appropriate design, construction, and workmanship for their intended use, so they can be adequately cleaned and maintained.
- Use containers and closures that are safe and suitable, and do not react with, add to, or absorb from the product so as to alter it.
- Establish and follow cleaning and maintenance schedules, and keep records.
- Maintain equipment in a condition that prevents contamination.
- Equipment or containers of unsuitable material or design that cannot be effectively cleaned.
- No cleaning/maintenance schedule, so equipment degrades into a contamination source.
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 1.1× the rate of the average FDA-cited firm (8.2% vs 7.8%), across 269 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
Failure to handle and maintain equipment, containers and utensils used to hold and store food in a manner that protects against contamination.
Failure to maintain equipment, containers and utensils used to convey food in a manner that protects against contamination.
Failure to maintain equipment, containers and utensils used to store food in a manner that protects against contamination.
Failure to maintain equipment, containers and utensils used to convey food in a manner that protects against contamination.
Failure to handle and maintain equipment, containers and utensils used to convey and hold food in a manner that protects against contamination.
Failure to maintain equipment, containers and utensils used to convey food 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 →