21 CFR 312.62(b) citations

Case history records- inadequate or inadequate

FDA investigators cited 21 CFR 312.62(b) 1,183 times at 1,120 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	32
2025	49
2024	56
2023	49
2022	36
2021	48
2020	30
2019	61
2018	69
2017	69

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	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jul 27, 2026	Blake G. Simmons, OD	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation and informed consent.
Jul 10, 2026	Zev Wainberg, M.D.	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jun 30, 2026	Sant P. Chawla, MD	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jun 25, 2026	Breelyn A Wilky MD	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jun 19, 2026	Maria Del Mar Garcia Romero, M.D.	Spain	Failure to prepare or maintain case histories with respect to observations and data pertinent to the investigation.
Jun 18, 2026	Dr. Amira Al-Uzri, M.D.	United States	Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation and informed consent.
Jun 16, 2026	Nonso Ezema, M.D., M.B.A.	United States	Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.
May 22, 2026	Keun-Wook Lee, M.D., Ph.D.	Korea (the Republic of)	Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.
May 12, 2026	Apinya B. Vutikullird, D.O.	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
May 7, 2026	Tamar F. Brionez, M.D.	United States	Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.
May 1, 2026	Jane M. Zochling, FRACP, PhD	Australia	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
May 1, 2026	Kenneth S. Sharlin, MD	United States	Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation and informed consent.
Apr 15, 2026	Kristen M. Pettit, M.D.	United States	Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.
Apr 3, 2026	Diana T. Widicus, M.D.	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Mar 27, 2026	Erica L. Mayer, M.D.	United States	Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.
Mar 27, 2026	Raed Al-Rajabi, MD	United States	Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.
Mar 13, 2026	Jeffrey R. Hoodin, M.D.	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Feb 26, 2026	Javier Martin-Broto, MD	Spain	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jan 29, 2026	Dr. Minoru Kato	Japan	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jan 29, 2026	Prof. Bernardo Leon Rapoport	South Africa	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jan 23, 2026	Gautam T. Jayram, M.D.	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Jan 16, 2026	William C. Nabours, M.D.	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Dec 18, 2025	Moraima Trujillo, M.D.	United States	Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
Dec 12, 2025	Hirotaka Nagashima	Japan	Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.

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.