FDA 483 OBSERVATION · #475 OF 1,932 MOST-CITED

Initial and continuing reviews

FDA cited this observation 53 times across 48 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 Monitoring53
BY FISCAL YEAR
FY20262
FY20251
FY20248
FY20231
FY20227
FY20204
FY20195
FY20187
FY20177
FY201611

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 0.5× the rate of the average FDA-cited firm (4.2% vs 7.8%), across 48 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.

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How FDA worded it — real examples

The IRB has no written procedure for conducting its initial and continuing review of research.

New York Presbyterian Brooklyn Methodist Hospital IRB · Brooklyn, New York · Bioresearch Monitoring · 2026-04-29

The IRB has no written procedure for conducting its initial review of research.

Kessler Foundation IRB · West Orange, New Jersey · Bioresearch Monitoring · 2026-01-15

The IRB has no written procedure for conducting its initial review of research.

Medical City Plano IRB · Plano, Texas · Bioresearch Monitoring · 2024-12-06

The IRB has no written procedure for conducting its review of research.

Saint Alphonsus Institutional Review Board · Boise, Idaho · Bioresearch Monitoring · 2024-09-18

The IRB did not follow its written procedure for conducting its initial review of research.

Clarus Safety Consulting, LLC · Schererville, Indiana · Bioresearch Monitoring · 2024-08-02

The IRB did not follow its written procedure for conducting its continuing review of research.

Maimonides Medical Center IRB · Brooklyn, New York · Bioresearch Monitoring · 2024-07-15

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 →