21 CFR 812.110(b) citations

Investigator non-compliance with agreement/plan/regulations

FDA investigators cited 21 CFR 812.110(b) 315 times at 309 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 14, 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 yearCitations
20266
20258
20247
20235
20226
20215
20208
201911
201818
201711

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 14, 2026Roderick H. Tung, M.D.United StatesAn investigation was not conducted in accordance with the investigational plan.
Mar 19, 2026Peter R. Movilla, MDUnited StatesAn investigation was not conducted in accordance with the investigational plan and conditions of approval imposed by an IRB.
Feb 24, 2026Stephane Leung Wai Sang, MDUnited StatesAn investigation was not conducted in accordance with the investigational plan.
Jan 16, 2026Ryan D. Snowden, MDUnited StatesAn investigation was not conducted in accordance with the investigational plan.
Jan 9, 2026Ripul R. Panchal, DOUnited StatesAn investigation was not conducted in accordance with the investigational plan.
Oct 1, 2025Alok Gambhir, MD, PhD.United StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
Aug 18, 2025Vincent DiGiovanni, DOUnited StatesAn investigation was not conducted in accordance with the investigational plan.
Aug 1, 2025Hatice (NMI) Hasturk, DDS, Ph.D.United StatesAn investigation was not conducted in accordance with the investigational plan.
Jun 27, 2025Srinivas Rao MyneniVenkatasatya, PhDUnited StatesAn investigation was not conducted in accordance with the investigational plan.
Jun 23, 2025Mark P. Christiansen, M.D.United StatesAn investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations.
Mar 17, 2025Deborah A. Goss, M.D.United StatesAn investigation was not conducted in accordance with the investigational plan.
Feb 7, 2025Jean F. Botha, M.D.United StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
Dec 10, 2024Tim Smith, M.D.United StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
Nov 22, 2024J. Scott Ferguson, MDUnited StatesAn investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations.
Aug 30, 2024Susan Seedman, M.D.United StatesAn investigation was not conducted in accordance with the investigational plan.
Jul 25, 2024John T. Perry, MDUnited StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
May 23, 2024Sajjad A. Sabir, M.D.United StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
May 3, 2024Mara Piltin, D.O.United StatesAn investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations.
Apr 26, 2024Patrick S. Kamath, M.D., Clinical InvestigatorUnited StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
Dec 20, 2023Dr. James A. Thompson, M.D.United StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
Oct 27, 2023Wayne M. Clark, MDUnited StatesAn investigation was not conducted in accordance with the investigational plan and applicable FDA regulations.
Aug 25, 2023Paul Sorajja, M.D.United StatesAn investigation was not conducted in accordance with the signed agreement, the investigational plan, applicable FDA regulations and conditions of approval imposed by an IRB.
Jun 20, 2023Dennis HammondUnited StatesAn investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations.
Mar 1, 2023Michael J Rosen MDUnited StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.
Feb 17, 2023Jorge L. Martinez Trabal, MDUnited StatesAn investigation was not conducted in accordance with the signed agreement and the investigational plan.

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