FDA 483 OBSERVATION · #631 OF 1,932 MOST-CITED

Members present for review

FDA cited this observation 36 times across 34 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 Monitoring36
BY FISCAL YEAR
FY20251
FY20241
FY20234
FY20223
FY20211
FY20203
FY20193
FY20186
FY20178
FY20166

What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.5× the rate of the average FDA-cited firm (11.8% vs 7.8%), across 34 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

For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

Nebraska Methodist Hospital IRB · Omaha, Nebraska · Bioresearch Monitoring · 2025-06-12

For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

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

For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

North Mississippi Health Services IRB · Tupelo, Mississippi · Bioresearch Monitoring · 2023-09-15

For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

Pomona Valley Hospital Medical Center IRB #1 · Pomona, California · Bioresearch Monitoring · 2023-06-28

For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

Children's Healthcare IRB #1 · Minneapolis, Minnesota · Bioresearch Monitoring · 2023-02-03

For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

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 →