FDA 483 OBSERVATION · #157 OF 1,923 MOST-CITED
Maintenance of equip., utensils, and finished food packaging
FDA cited this observation 196 times across 191 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.
Equipment, utensils, and finished-food containers were not maintained in a condition that protects food — worn or cracked surfaces, corrosion, flaking coatings, poorly maintained seams, or damaged food-contact packaging. This is the equipment-and-utensils requirement of §117.40, covering design, construction, and upkeep so surfaces stay cleanable and non-contaminating.
Why FDA writes it — Deteriorated equipment and utensils shed metal, rust, plastic, or coating into food and harbor microbes in cracks and pits that cleaning cannot reach; damaged packaging fails to protect the finished product. FDA cites this because equipment that cannot be kept clean and intact is itself a source of physical and microbial contamination.
- Design and select food-contact equipment and utensils from cleanable, corrosion-resistant, non-toxic materials with accessible construction.
- Run a preventive-maintenance program that inspects for wear, cracks, corrosion, and flaking and replaces or repairs before they contaminate food.
- Inspect finished-food packaging and container-forming equipment so seams, seals, and surfaces protect the product.
- Keep maintenance and inspection records that document condition over time and drive timely repair or replacement.
- Run-to-failure maintenance culture, so equipment degrades into a contamination source before it is addressed.
- Food-contact condition (cracks, pitting, flaking coating) not part of the maintenance inspection scope, only mechanical function.
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 (8.4% vs 7.8%), across 191 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 maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.
Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.
Failure to maintain equipment, utensils and finished food containers in an acceptable condition through appropriate cleaning and sanitizing.
Failure to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing.
Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.
Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.
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 →