FDA 483 OBSERVATION · #1487 OF 1,918 MOST-CITED
Prompt reporting of unanticipated problems
FDA cited this observation 8 times across 8 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.
How FDA worded it — real examples
The IRB has no written procedures for ensuring prompt reporting to appropriate institutional officials and the FDA of any unanticipated problems involving risks to human subjects or others.
The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials and the FDA of any unanticipated problems involving risks to human subjects or others.
The IRB has no written procedures for ensuring prompt reporting to appropriate institutional officials and the FDA of any unanticipated problems involving risks to human subjects or others.
The IRB did not follow written procedures for ensuring prompt reporting to the FDA of any unanticipated problems involving risks to human subjects or others.
The IRB did not follow written procedures for ensuring prompt reporting to the IRB of any unanticipated problems involving risks to human subjects or others.
The IRB has no written procedures for ensuring prompt reporting to the FDA of any unanticipated problems involving risks to human subjects or others.
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 →