FDA 483 OBSERVATION · #55 OF 1,923 MOST-CITED
Equipment Design, Size and Location
FDA cited this observation 445 times across 397 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 and utensils were not of appropriate design, size, or installation/location to be adequately cleanable and to be maintained in a way that prevents contamination of food.
Why FDA writes it — Design, size, and placement determine whether equipment can actually be cleaned and maintained. Equipment that is poorly designed or crammed into inaccessible locations cannot be reliably sanitized, making it a persistent contamination source regardless of cleaning effort.
- Use equipment and utensils designed and of such material and workmanship that they can be adequately cleaned and properly maintained.
- Install and locate equipment to facilitate cleaning of the equipment and of adjacent spaces.
- Ensure seams on food-contact surfaces are smoothly bonded or maintained to minimize accumulation of food particles, dirt, and organic matter.
- Size and space equipment so all surfaces can be reached and cleaned.
- Equipment placed where surfaces and surroundings cannot be reached for cleaning.
- Designs with crevices or rough seams that trap residue and resist sanitation.
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 5.2× the rate of the average FDA-cited firm (40.3% vs 7.8%), across 397 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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
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 →