Overview
- 50 inspections across 48 sites are on record.
- 204 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-03-05.
At a glance
Inspections
50
Sites
48
Observations
204
Career since
Jul 2021
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Gentuity, LLC | 5 Mar 2026 | Medical Devices & Rad Health | On file |
| Ives EEG Solutions, LLC | 6 Feb 2026 | Medical Devices & Rad Health | |
| ZIOSOFT, INC. | 18 Dec 2025 | Medical Devices & Rad Health | On file |
| SMC | 11 Dec 2025 | Medical Devices & Rad Health | On file |
| Huons Co., Ltd. | 3 Dec 2025 | Medical Devices & Rad Health |
Sites inspected
Gentuity, LLCSudbury, United States1 insp.
Ives EEG Solutions, LLCNewburyport, United States1 insp.
ZIOSOFT, INC.Minato, Japan1 insp.
SMCGimpo, Korea (the Republic of)1 insp.
Huons Co., Ltd.Jecheon, Korea (the Republic of)1 insp.
Co-investigators
Investigators who share inspections with this person.
Nabil Nakhoul3 shared
James P Finn2 shared
Kayla R Huffman1 shared
Sara M Onyango1 shared
David C Sullivan1 shared
Diane M Biron1 shared
Justine M Corson1 shared
Full investigator report
Get the verbatim findings behind Sunita Pandey's 204 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