21 CFR 312.60 citations

Informed consent

FDA investigators cited 21 CFR 312.60 2,172 times at 1,862 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 28, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal year	Citations
2026	69
2025	84
2024	104
2023	103
2022	77
2021	90
2020	58
2019	128
2018	122
2017	137

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection ended	Facility	Country	Observation
Aug 28, 2026	Robert B. Molpus, M.D.	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Jul 27, 2026	Blake G. Simmons, OD	United States	An investigation was not conducted in accordance with the signed statement of investigator.
Jul 17, 2026	Alexander Glaros, M.D.	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Jul 2, 2026	Dayan K. Gandhi, M.D.	United States	An investigation was not conducted in accordance with the investigational plan.
Jun 30, 2026	Sant P. Chawla, MD	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Jun 26, 2026	Binod Dhakal, MD	United States	An investigation was not conducted in accordance with the investigational plan.
Jun 25, 2026	Breelyn A Wilky MD	United States	An investigation was not conducted in accordance with the signed statement of investigator.
Jun 19, 2026	Maria Del Mar Garcia Romero, M.D.	Spain	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Jun 18, 2026	Florence Lerebours, M.D.	France	An investigation was not conducted in accordance with the investigational plan.
Jun 16, 2026	Nonso Ezema, M.D., M.B.A.	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Jun 15, 2026	Claudia T. Martorell, M.D.	United States	An investigation was not conducted in accordance with the investigational plan.
Jun 11, 2026	Antoine Hollebecque, M.D.	France	An investigation was not conducted in accordance with the investigational plan.
Jun 10, 2026	Yuh-Chin T. Huang, MD	United States	An investigation was not conducted in accordance with the investigational plan.
May 21, 2026	Kimball A. Johnson, M.D.	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
May 21, 2026	Vaibhav Daulat Pandharkar, MBBS	India	An investigation was not conducted in accordance with the investigational plan.
May 12, 2026	Apinya B. Vutikullird, D.O.	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
May 7, 2026	Tamar F. Brionez, M.D.	United States	An investigation was not conducted in accordance with the investigational plan.
May 1, 2026	Eduardo E. Rodriguez-Araya, MD	United States	An investigation was not conducted in accordance with the investigational plan.
May 1, 2026	Kenneth S. Sharlin, MD	United States	An investigation was not conducted in accordance with the investigational plan.
Apr 30, 2026	Prithviraj Bose, M.D.	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Apr 24, 2026	Brian C. DeBeaubien, M.D.	United States	An investigation was not conducted in accordance with the investigational plan.
Apr 17, 2026	Sergio Andres Nemi, MD	Argentina	An investigation was not conducted in accordance with the investigational plan.
Apr 15, 2026	Kristen M. Pettit, M.D.	United States	An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
Apr 13, 2026	Harry S. Menon, D.O.	United States	An investigation was not conducted in accordance with the investigational plan.
Apr 1, 2026	Cameron Olezene, M.D.	United States	An investigation was not conducted in accordance with the investigational plan.

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