21 CFR 312.62(a) citations
FDA investigators cited 21 CFR 312.62(a) 370 times at 352 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 23, 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 | 3 |
| 2025 | 9 |
| 2024 | 6 |
| 2023 | 9 |
| 2022 | 13 |
| 2021 | 13 |
| 2020 | 11 |
| 2019 | 18 |
| 2018 | 16 |
| 2017 | 18 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jan 23, 2026 | Gautam T. Jayram, M.D. | United States | Investigational drug disposition records are not adequate with respect to use by subjects. |
| Dec 23, 2025 | Rogelio Machuca, MD | United States | Investigational drug disposition records are not adequate with respect to quantity and use by subjects. |
| Oct 10, 2025 | Evan Russell, DO | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Aug 1, 2025 | Hummayun Ismail, M.D. | United States | Investigational drug disposition records are not adequate with respect to quantity. |
| Jun 18, 2025 | David Pham, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Jun 13, 2025 | Keith M. Wan, O.D. | United States | Investigational drug disposition records are not adequate with respect to use by subjects. |
| May 28, 2025 | Amylynne J. Frankel, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Mar 14, 2025 | Asim Roy, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Mar 13, 2025 | Naseem A. Jaffrani, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Jan 31, 2025 | Ida Vanessa Doederlein Schwartz, MD | Brazil | Investigational drug disposition records are not adequate with respect to quantity and use by subjects. |
| Oct 15, 2024 | Pamela K. Den Besten, DDS | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Oct 4, 2024 | Haider Afzal, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Sep 25, 2024 | Steven E. Chavoustie, MD | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Jul 16, 2024 | Peet John J MD | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Apr 15, 2024 | John J. Wrenn, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Mar 7, 2024 | Janaki (NMI) Nadarajah DPM | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Feb 15, 2024 | George Timothy Kelly. M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Dec 5, 2023 | Adam J. Wolff, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates. |
| Sep 14, 2023 | Vinay Sikand, M.D. | United States | Investigational drug disposition records are not adequate with respect to quantity and use by subjects. |
| Sep 1, 2023 | Brian B. Borg, M.D. | United States | Investigational drug disposition records are not adequate with respect to quantity and use by subjects. |
| Aug 21, 2023 | Ahsan A. Abdulghani, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates and use by subjects. |
| May 25, 2023 | Veronique Sebastian, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Apr 11, 2023 | Elijah W. Stommel, M.D. | United States | Investigational drug disposition records are not adequate with respect to use by subjects. |
| Jan 26, 2023 | Sloan W. Rush, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
| Jan 13, 2023 | Steven D. Folkerth, M.D. | United States | Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects. |
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