FDA 483 OBSERVATION · #147 OF 1,923 MOST-CITED
Materials and workmanship
FDA cited this observation 206 times across 202 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.
Finished devices exhibit defects in materials or workmanship that acceptance activities failed to detect or reject — meaning receiving, in-process, and finished-device acceptance under §820.80 did not ensure that incoming materials and completed units conformed to specified requirements before use or release.
Why FDA writes it — Acceptance activities are the control that keeps nonconforming material and defective assembly out of finished product. FDA protects against shipping devices with substandard materials or defective workmanship that could fail in clinical use, because the acceptance gates that should have caught them were absent or ineffective.
- Define objective acceptance criteria for materials and workmanship at receiving, in-process, and finished-device stages per §820.80.
- Document acceptance or rejection with the equipment used and the personnel performing it, and hold product until accepted.
- Establish clear reject/segregation flows so material failing workmanship criteria cannot advance to release.
- Trend acceptance and rejection data to detect supplier or process degradation before it reaches finished product.
- Workmanship standards are subjective (no boundary samples or photos), so inspectors pass borderline defects.
- Incoming material acceptance is skipped for "trusted" suppliers, letting substandard lots into production.
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 (9.4% vs 7.8%), across 202 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
The design, materials and workmanship of equipment does not allow proper cleaning and maintenance.
The materials of equipment does not allow proper cleaning.
The design and materials of equipment does not allow proper cleaning and maintenance.
The design of equipment does not allow proper cleaning.
The materials of equipment does not allow proper cleaning.
The materials of utensils does not allow proper cleaning and maintenance.
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 →