Overview
- 61 inspections across 60 sites are on record.
- 36 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-06-30.
At a glance
Inspections
61
Sites
60
Observations
36
Career since
Jan 2022
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Eileen O'Reilly, M.D. | 30 Jun 2026 | Human Drugs | |
| Dr. Mahesh G. Bhirud, M.D. | 22 May 2026 | Human Drugs | On file |
| Rajendra Sonde, M.B.B.S. | 9 May 2026 | Human Drugs | |
| Alkem Laboratories Ltd., Bioequivalence Centre | 8 May 2026 | Human Drugs | |
| Dr. Mitulkumar Manubhai Chaudhari, M.D. | 24 Apr 2026 | Human Drugs |
Sites inspected
Eileen O'Reilly, M.D.New York, United States1 insp.
Dr. Mahesh G. Bhirud, M.D.Nashik, India1 insp.
Rajendra Sonde, M.B.B.S.Mumbai, India1 insp.
Alkem Laboratories Ltd., Bioequivalence CentreNavi Mumbai, India1 insp.
Dr. Mitulkumar Manubhai Chaudhari, M.D.Himatnagar, India1 insp.
Co-investigators
Investigators who share inspections with this person.
Omadevi Somai6 shared
Benton M Ketron5 shared
Roberto A Dookhan2 shared
Alanna L Mussawwir Bias2 shared
Scott B Laufenberg2 shared
Byungja E Marciante2 shared
Yuyan Liang2 shared
Jennifer C Adams1 shared
Simona M Bancos1 shared
Gabrielle J Swain1 shared
Full investigator report
Get the verbatim findings behind Kerun Hardeo's 36 observations
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site