FDA 483 OBSERVATION · #911 OF 1,000 MOST-CITED
Prompt reporting of noncompliance
FDA cited this observation 19 times across 19 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 IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials and the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.
The IRB has no written procedures for ensuring prompt reporting to appropriate institutional officials and the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.
The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials and the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.
The IRB did not follow written procedures for ensuring prompt reporting to the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.
The IRB did not follow written procedures for ensuring prompt reporting to appropriate institutional officials and the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.
The IRB did not follow written procedures for ensuring prompt reporting to the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.
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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