FDA 483 OBSERVATION · #103 OF 1,923 MOST-CITED
Investigation of device failures
FDA cited this observation 289 times across 270 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.
The device manufacturer did not adequately investigate device failures surfaced through complaints (or other sources), so the causes of failures — and whether they were reportable — were not properly determined.
Why FDA writes it — Device failures are signals of a quality or safety problem. Failing to investigate them means recurring failures go uncorrected and reportable events go unreported, defeating both CAPA and the FDA’s market-wide safety surveillance.
- Investigate complaints involving possible failure of a device to meet its specifications, unless a similar failure was already investigated.
- Determine the cause where practicable, and feed systemic causes into CAPA.
- Screen each failure for MDR reportability and report reportable events on time.
- Document the investigation, its conclusions, and any corrective action.
- Device failures closed without investigation or root cause.
- No screen for MDR reportability within the failure investigation.
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 1.3× the rate of the average FDA-cited firm (10.0% vs 7.8%), across 270 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
Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Complaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary.
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 →