FDA 483 OBSERVATION · #1095 OF 1,932 MOST-CITED

ClincialTrials.gov statement

FDA cited this observation 15 times across 15 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 Monitoring15
BY FISCAL YEAR
FY20252
FY20231
FY20222
FY20212
FY20171
FY20167

How FDA worded it — real examples

The informed consent document does not include the required statement: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Happy Health Inc · Austin, Texas · Bioresearch Monitoring · 2025-05-29

The informed consent document does not include the required statement: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Julia C. Carnevale, M.D. · San Francisco, California · Bioresearch Monitoring · 2024-12-12

The informed consent document does not include the required statement: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

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

The informed consent document does not include the required statement: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Daniel Fred Goodman, M.D. · San Francisco, California · Bioresearch Monitoring · 2021-12-13

The informed consent document does not include the required statement: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Larkin Community Hospital IRB · South Miami, Florida · Bioresearch Monitoring · 2021-11-19

The informed consent document does not include the required statement: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Richard J. Obiso, PhD dba Avila Herbals, LLC · Christiansburg, Virginia · Bioresearch Monitoring · 2021-07-26

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 →