FDA Person
FDASunita Pandey
View detailed information about Sunita Pandey, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 38 inspections of 36 companies, 2023–2026.
Inspections (38)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| July 24, 2026 | Louis M. Gerson Co., Inc. | VAI | Compliance: Devices | #1329546 |
| June 3, 2026 | Fresenius Medical Care Holdings, Inc. | Not classified | Compliance: Devices | #1322950 |
| March 5, 2026 | Gentuity, LLC | Not classified | Compliance: Medical Devices | #1307694 |
| February 6, 2026 | Ives EEG Solutions, LLC | NAI | Postmarket Assurance: Devices | #1302196 |
| December 18, 2025 | ZIOSOFT, INC. | VAI | Compliance: Medical Devices | #1296688 |
| December 11, 2025 | SMC | VAI | Compliance: Medical Devices | #1296686 |
| December 3, 2025 | Huons Co., Ltd. - Jecheon Factory | Not classified | #1287330 | |
| November 21, 2025 | 3D Diagnostix Inc. | VAI | Compliance: Medical Devices | #1292268 |
| October 22, 2025 | Autocam Medical Devices, LLC | VAI | Compliance: Medical Devices | #1290184 |
| September 19, 2025 | MAR-LEE Companies, Inc. | NAI | Compliance: Devices | #1282990 |
| August 26, 2025 | Magellan Diagnostics, Inc. | OAI | Compliance: Medical Devices | #1280392 |
| July 10, 2025 | Sirtex Wilmington LLC | VAI | Compliance: Medical Devices | #1267696 |
| May 20, 2025 | OrthoFundamentals, Llc | NAI | Postmarket Assurance: Medical Devices | #1271579 |
| April 15, 2025 | ZOLL Medical Corporation | OAI | Compliance: Medical Devices | #1246565 |
| January 22, 2025 | HIPP medical AG | Not classified | #1261902 | |
| January 22, 2025 | HIPP medical AG | NAI | Compliance: Devices | #1261902 |
| January 16, 2025 | Audifon Gmbh | VAI | Compliance: Medical Devices | #1260616 |
| January 9, 2025 | Ortec | OAI | Postmarket Assurance: Devices | #1260617 |
| January 9, 2025 | Kabe Labortechnik Gmbh | OAI | Compliance: Medical Devices | #1260617 |
| November 27, 2024 | Draeger Medical Systems, Inc. | Not classified | #1256505 |
Documents (34)
- 483 · Med Pen Concepts, LLC · January 24, 2024
- 483 · Autocam Medical Devices, LLC · October 22, 2025
- 483 · AmericanBio Inc. · November 4, 2021
- 483 · DUSA Pharmaceuticals, Inc. · September 8, 2023
- 483 · Gyrus ACMI, Inc. · November 2, 2023
- 483 · Lymol Medical Corporation · July 29, 2021
- 483 · Biosensics LLC · April 7, 2023
- 483 · Whele LLC DBA Perch · June 6, 2022
- 483 · Magellan Diagnostics, Inc. · August 26, 2025
- 483 · Kabe Labortechnik Gmbh · January 9, 2025
- 483 · ZOLL Medical Corporation · April 15, 2025
- 483 · Sirtex Wilmington LLC · July 10, 2025
- 483 · Fresenius Medical Care Holdings, Inc. · October 16, 2024
- 483 · Hightech American Industrial Laboratories, Inc. · January 25, 2022
- 483 · OrthoFundamentals, Llc · May 20, 2025
- 483 · Foresight Imaging, LLC · December 20, 2022
- 483 · Conformis, Inc. · March 9, 2023
- 483 · TAMPON INNOVATIONS LTD. · July 11, 2024
- 483 · Beeken Biomedical, LLC · July 8, 2021
- 483 · Fresenius Medical Care Holdings, Inc. · August 2, 2023
- 483 · Little Sparrows Technologies, Inc. · October 20, 2021
- 483 · Cardinal Health · July 18, 2022
- 483 · LeMaitre Vascular, Inc. · May 16, 2023
- 483 · Med Pen Concepts, LLC · April 13, 2022
- 483 · Primrose Medical Inc. · October 26, 2022
- 483 · Covidien LP · November 18, 2022
- 483 · Lifeline Systems Company · August 17, 2022
- 483 · SRS Medical Systems Inc. · October 11, 2023
- 483 · Fresenius Medical Care Holdings, Inc. · September 16, 2024
- 483 · SMC · December 11, 2025
- 483 · ZOLL Medical Corporation · April 15, 2025
- 483 · Fresenius Medical Care Holdings, Inc. · June 3, 2026
- 483 · 3D Diagnostix Inc. · November 21, 2025
- 483 · Gentuity, LLC · March 5, 2026
Frequently inspected with (1)
Person Information
Name
Sunita Pandey
Role
ISSUING OFFICER
ID: 008e5bb8-0eb3-45d8-8524-734ac0454250
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