FDA 483 OBSERVATION · #123 OF 1,923 MOST-CITED
Individual Report of Malfunction
FDA cited this observation 247 times across 223 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 manufacturer failed to submit, or submitted late or incompletely, an individual Medical Device Report (MDR) for an event where its device malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur, as required under 21 CFR Part 803.
Why FDA writes it — MDR is FDA’s post-market safety signal system. A missed or late malfunction report deprives the agency and the public of the data needed to detect a dangerous trend across the installed base — the risk is a systemic device failure spreading before the signal is ever seen.
- Maintain written MDR procedures that define reportable malfunctions and the 30-day individual-report clock from becoming aware.
- Route every complaint through an MDR reportability decision with a documented, defensible rationale.
- File FDA Form 3500A for each reportable malfunction within the required timeframe and retain the reportability assessment.
- Reconcile complaint files against MDR submissions periodically to catch events that were closed without a reportability call.
- Complaint handlers apply an overly narrow "malfunction" definition and under-report likely-to-recur events.
- The 30-day clock is missed because "became aware" is interpreted from formal confirmation rather than first awareness.
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 2.3× the rate of the average FDA-cited firm (17.5% vs 7.8%), across 223 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
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
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 →