Home / CFR sections / 21 CFR 812.100

21 CFR 812.100 citations

No investigator protection - subject rights, safety, welfare

FDA investigators cited 21 CFR 812.100 375 times at 311 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 6, 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
202614
202514
20246
20239
20221
20214
20209
20196
201818
201718

Recent citations

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

Inspection endedFacilityCountryObservation
Aug 6, 2026Mark Clemens M.D.United StatesAn investigation was not conducted according to the signed agreement, investigational plan and applicable FDA regulations.
Jul 21, 2026Endovascular Engineering, IncUnited StatesAn investigation was not conducted according to the investigational plan.
Mar 27, 2026Benjamin D. Elder, MD, PhDUnited StatesAn investigation was not conducted according to the investigational plan.
Mar 23, 2026Terence T. Sio, M.D., M.S.United StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Mar 20, 2026Rishi K. Wadhwa, M.D.United StatesAn investigation was not conducted according to the signed agreement, investigational plan and applicable FDA regulations.
Feb 27, 2026Wilber W. Su, MDUnited StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Feb 27, 2026Ziv J. Haskal, MDUnited StatesAn investigation was not conducted according to the investigational plan.
Feb 13, 2026Kevin E. Miller, MDUnited StatesAn investigation was not conducted according to the investigational plan.
Jan 15, 2026Carlos Timaran, MDUnited StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Dec 31, 2025Jae S. Cho, M.DUnited StatesAn investigation was not conducted according to the signed agreement.
Dec 19, 2025Thomas Jared BunchUnited StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Oct 10, 2025Michael T. Somenek, M.D.United StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Oct 9, 2025Edmundowicz, Dr StevenUnited StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Oct 1, 2025Alok Gambhir, MD, PhD.United StatesInformed consent was not obtained in accordance with the regulations regarding the protection of human subjects.
Sep 30, 2025David V. Daniels, MDUnited StatesAn investigation was not conducted according to the signed agreement, investigational plan and applicable FDA regulations.
Sep 26, 2025Vladmir M. Kushnir, MDUnited StatesAn investigation was not conducted according to the investigational plan.
Aug 15, 2025Cassius I. O. Chaar, M.D.United StatesAn investigation was not conducted according to the investigational plan.
Aug 15, 2025Khanjan H. Nagarsheth, MDUnited StatesAn investigation was not conducted according to the investigational plan.
Jul 21, 2025Robert E. Beasley, MDUnited StatesAn investigation was not conducted according to the investigational plan.
Jul 17, 2025Sijo J. Parekattil, M.D.United StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Jun 9, 2025Stephen J. Monteith, MDUnited StatesAn investigation was not conducted according to the signed agreement and investigational plan.
May 29, 2025Happy Health IncUnited StatesInformed consent was not obtained in accordance with the regulations regarding the protection of human subjects.
Apr 11, 2025Michael D. Greenwood, MDUnited StatesAn investigation was not conducted according to the signed agreement and investigational plan.
Feb 14, 2025Waclaw B. Kuczmik, M.D. PhDPolandAn investigation was not conducted according to the investigational plan.
Jan 31, 2025Anish J. Thomas, M.D.United StatesAn investigation was not conducted according to the investigational plan.

Search more

Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.