FDA 483 OBSERVATION · #1176 OF 1,932 MOST-CITED

Written procedures per 56.108(a) and (b)

FDA cited this observation 13 times across 12 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 Monitoring13
BY FISCAL YEAR
FY20241
FY20221
FY20211
FY20203
FY20184
FY20172
FY20161

How FDA worded it — real examples

Documentation has not been prepared of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).

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

Documentation has not been prepared and maintained of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).

Centracare St. Cloud Hospital - Irb · Saint Cloud, Minnesota · Bioresearch Monitoring · 2022-02-18

Documentation has not been prepared of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).

Summa Health System IRB · Akron, Ohio · Bioresearch Monitoring · 2020-10-07

Documentation has not been prepared and maintained of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).

Copley Memorial Hospital IRB · Aurora, Illinois · Bioresearch Monitoring · 2020-02-10

Documentation has not been prepared of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).

Naval Medical Center San Diego IRB · San Diego, California · Bioresearch Monitoring · 2019-11-20

Documentation has not been prepared of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).

Jewish Hospital IRB · Cincinnati, Ohio · Bioresearch Monitoring · 2019-10-17

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.

Pharmaceutical quality system →GCP discipline →

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