FDA 483 OBSERVATION · #1279 OF 1,932 MOST-CITED

Copy of consent form not provided

FDA cited this observation 11 times across 11 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 Monitoring11
BY FISCAL YEAR
FY20262
FY20232
FY20212
FY20201
FY20191
FY20181
FY20171
FY20161

How FDA worded it — real examples

A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.

Eduardo E. Rodriguez-Araya, MD · New Orleans, Louisiana · Bioresearch Monitoring · 2026-05-01

A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.

Javier Sosa Faria, M.D. · Ponce, Puerto Rico · Bioresearch Monitoring · 2025-10-31

A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.

Lewis, Karl D. MD · Aurora, Colorado · Bioresearch Monitoring · 2023-08-07

A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.

Raymond E. Easley, D.O. · Snellville, Georgia · Bioresearch Monitoring · 2023-05-26

A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.

Maggie A. Jeffries, M.D. · Houston, Texas · Bioresearch Monitoring · 2021-08-05

A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.

Jeffrey S. Dome, M.D. · Washington, District of Columbia · Bioresearch Monitoring · 2021-04-12

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.

GCP discipline →

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