FDA 483 OBSERVATION · #301 OF 1,923 MOST-CITED
Lack of System for Event Evaluations
FDA cited this observation 97 times across 94 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 is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 2.2× the rate of the average FDA-cited firm (17.0% vs 7.8%), across 94 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 written MDR Procedure does not include an internal system which provides for timely and effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
The written MDR Procedure does not include an internal system which provides for timely and effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
The written MDR Procedure does not include an internal system which provides for timely and effective communication of events that may be subject to medical device reporting requirements.
The written MDR Procedure does not include an internal system which provides for timely and effective identification and evaluation of events that may be subject to medical device reporting requirements.
The written MDR Procedure does not include an internal system which provides for timely and effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
The written MDR Procedure does not include an internal system which provides for timely and effective communication of events that may be subject to medical device reporting requirements.
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 →