FDA 483 OBSERVATION · #926 OF 1,932 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.

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.

BY PROGRAM AREA
Bioresearch Monitoring19
BY FISCAL YEAR
FY20261
FY20242
FY20233
FY20221
FY20211
FY20201
FY20191
FY20183
FY20174
FY20162

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.

Wills Eye Hospital IRB · Philadelphia, Pennsylvania · Bioresearch Monitoring · 2025-10-17

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.

Bay Area Tumor Institute IRB · Oakland, California · Bioresearch Monitoring · 2023-12-14

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.

ACMH Hospital IRB · Kittanning, Pennsylvania · Bioresearch Monitoring · 2023-11-08

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.

Baton Rouge General Medical Center IRB · Baton Rouge, Louisiana · Bioresearch Monitoring · 2023-09-14

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.

Louisiana State University Health Sciences Center IRB · New Orleans, Louisiana · Bioresearch Monitoring · 2023-07-26

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.

N.Y.S. Psychiatric Institute IRB · New York, New York · Bioresearch Monitoring · 2023-02-02

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.

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Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →