FDA 483 OBSERVATION · #288 OF 1,000 MOST-CITED
Lack of System for Event Evaluations
FDA cited this observation 76 times across 73 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.
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 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.
The written MDR Procedure does not include an internal system which provides for timely and effective evaluation 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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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