21 CFR 812.110(b) citations
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 year | Citations |
|---|---|
| 2026 | 6 |
| 2025 | 8 |
| 2024 | 7 |
| 2023 | 5 |
| 2022 | 6 |
| 2021 | 5 |
| 2020 | 8 |
| 2019 | 11 |
| 2018 | 18 |
| 2017 | 11 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 14, 2026 | Roderick H. Tung, M.D. | United States | An investigation was not conducted in accordance with the investigational plan. |
| Mar 19, 2026 | Peter R. Movilla, MD | United States | An investigation was not conducted in accordance with the investigational plan and conditions of approval imposed by an IRB. |
| Feb 24, 2026 | Stephane Leung Wai Sang, MD | United States | An investigation was not conducted in accordance with the investigational plan. |
| Jan 16, 2026 | Ryan D. Snowden, MD | United States | An investigation was not conducted in accordance with the investigational plan. |
| Jan 9, 2026 | Ripul R. Panchal, DO | United States | An investigation was not conducted in accordance with the investigational plan. |
| Oct 1, 2025 | Alok Gambhir, MD, PhD. | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| Aug 18, 2025 | Vincent DiGiovanni, DO | United States | An investigation was not conducted in accordance with the investigational plan. |
| Aug 1, 2025 | Hatice (NMI) Hasturk, DDS, Ph.D. | United States | An investigation was not conducted in accordance with the investigational plan. |
| Jun 27, 2025 | Srinivas Rao MyneniVenkatasatya, PhD | United States | An investigation was not conducted in accordance with the investigational plan. |
| Jun 23, 2025 | Mark P. Christiansen, M.D. | United States | An investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations. |
| Mar 17, 2025 | Deborah A. Goss, M.D. | United States | An investigation was not conducted in accordance with the investigational plan. |
| Feb 7, 2025 | Jean F. Botha, M.D. | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| Dec 10, 2024 | Tim Smith, M.D. | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| Nov 22, 2024 | J. Scott Ferguson, MD | United States | An investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations. |
| Aug 30, 2024 | Susan Seedman, M.D. | United States | An investigation was not conducted in accordance with the investigational plan. |
| Jul 25, 2024 | John T. Perry, MD | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| May 23, 2024 | Sajjad A. Sabir, M.D. | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| May 3, 2024 | Mara Piltin, D.O. | United States | An investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations. |
| Apr 26, 2024 | Patrick S. Kamath, M.D., Clinical Investigator | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| Dec 20, 2023 | Dr. James A. Thompson, M.D. | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| Oct 27, 2023 | Wayne M. Clark, MD | United States | An investigation was not conducted in accordance with the investigational plan and applicable FDA regulations. |
| Aug 25, 2023 | Paul Sorajja, M.D. | United States | An 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, 2023 | Dennis Hammond | United States | An investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations. |
| Mar 1, 2023 | Michael J Rosen MD | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
| Feb 17, 2023 | Jorge L. Martinez Trabal, MD | United States | An investigation was not conducted in accordance with the signed agreement and the investigational plan. |
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