FDA Person
FDAKwong P. Lee
View detailed information about Kwong P. Lee, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 117 inspections of 113 companies, 2016–2026.
Inspections (117)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 24, 2026 | Gambro Industries SAS | Not classified | Postmarket Assurance: Devices | #1338846 |
| March 30, 2026 | Magnus Medical, Inc. | Not classified | Compliance: Devices | #1310046 |
| March 25, 2026 | Neurotrack Technologies | Not classified | Compliance: Devices | #1309246 |
| March 3, 2026 | Medivis, Inc. | Not classified | Compliance: Medical Devices | #1307926 |
| December 23, 2025 | Strides Pharma, Inc. | Not classified | #1292202 | |
| September 25, 2025 | Mesco, Inc. | NAI | Postmarket Assurance: Medical Devices | #1283366 |
| September 18, 2025 | BCM Co., Ltd. | NAI | Postmarket Assurance: Medical Devices | #1282002 |
| September 11, 2025 | CG Bio Co., Ltd. | NAI | Postmarket Assurance: Medical Devices | #1281106 |
| September 11, 2025 | CG MedTech Co. Ltd | VAI | Compliance: Devices | #1281106 |
| August 28, 2025 | Kaneka Medical America LLC | Not classified | #1287756 | |
| July 30, 2025 | ZiphyCare, Inc. | VAI | Compliance: Medical Devices | #1276945 |
| July 25, 2025 | Statsure Diagnostic Systems | Not classified | #1277668 | |
| May 22, 2025 | DuoProSS Meditech Corporation | Not classified | #1275558 | |
| April 14, 2025 | GCE International, Inc. | NAI | Compliance: Devices | #1273161 |
| April 4, 2025 | Flexbar Machine Corp | NAI | Compliance: Medical Devices | #1266364 |
| March 12, 2025 | Voom Medical Devices, LLC | NAI | Compliance: Devices | #1265072 |
| February 21, 2025 | Isomedix Operations Inc. | NAI | Compliance: Devices | #1264291 |
| January 28, 2025 | Ezar AI, Inc. | VAI | Compliance: Medical Devices | #1259330 |
| January 10, 2025 | Redicare LLC | VAI | Compliance: Medical Devices | #1258134 |
| December 12, 2024 | Isomedix Operations, Inc | VAI | Compliance: Medical Devices | #1256809 |
Documents (80)
- EIR · Xtreem Pulse LLC · June 19, 2019
- 483 · Xtreem Pulse LLC · June 19, 2019
- 483 · Olaregen Therapeutix Inc. · April 3, 2020
- 483 · HansBiomed USA, Inc. · November 8, 2022
- 483 · Allstar Marketing Group Llc · March 21, 2022
- 483 · Phamedica Inc. · January 10, 2020
- 483 · Nipro (Thailand) Corporation Limited · May 3, 2018
- 483 · TAMA Research Corporation · April 22, 2019
- 483 · Precipart Corp · February 25, 2021
- 483 · Hobbs Medical, Inc. · August 27, 2021
- 483 · Perrigo New York, Inc. · October 24, 2022
- 483 · Anschel Technology Inc. · December 31, 2019
- 483 · ImaCor Inc. · June 10, 2021
- 483 · Distron Corporation · March 20, 2024
- 483 · Strides Pharma, Inc. · December 23, 2025
- 483 · Isomedix Operations, Inc · December 12, 2024
- 483 · Redicare LLC · January 10, 2025
- 483 · Ezar AI, Inc. · January 28, 2025
- 483 · ZiphyCare, Inc. · July 30, 2025
- 483 · Beverly Hills Uniforms · October 26, 2021
- 483 · Flexbar Machine Corp · April 4, 2025
- 483 · Nature Major Inc · February 28, 2020
- 483 · Equashield LLC · December 8, 2021
- 483 · Advanced Monitored Caregiving, Inc. · November 12, 2020
- 483 · Aeye Health Inc. · March 15, 2024
- 483 · eCordum, Inc. · July 12, 2023
- 483 · Red Medical Solutions, Inc. · March 22, 2023
- 483 · J & J Instruments, LLC · September 16, 2020
- 483 · Metropolis International LLC · January 27, 2023
- 483 · TMRW Life Sciences, Inc. · October 24, 2023
- 483 · Biodex Medical Systems, Inc. · February 10, 2023
- 483 · Cogentix Medical, Inc. · April 14, 2022
- 483 · K2 Health Products LLC · November 15, 2022
- 483 · Sage Product Development, Inc. · April 4, 2024
- 483 · Avery Biomedical Devices, Inc. · July 16, 2019
- 483 · Neurodynamics, Inc. · July 21, 2021
- 483 · Spectronics Corp · January 30, 2020
- 483 · E-Beam Services, Inc. · April 27, 2023
- 483 · Promade POC Center for Complex Orthopedic Solutions at HHS · January 18, 2024
- 483 · NYSARC, Columbia County Chapter, Inc. · May 13, 2022
- 483 · Treestone Trading Group LLC · February 14, 2020
- 483 · Aerolase Corp. · August 8, 2019
- 483 · Neurodynamics, Inc. · February 28, 2024
- 483 · AMCO International Manufacturing & Design, Inc. · May 27, 2021
- 483 · Blue Chip Medical Products, Inc. · February 18, 2022
- 483 · Enter Medical Corporation · February 28, 2019
- 483 · W.A. Baum Co. Inc. · June 16, 2021
- 483 · Remote Technologies, Inc. · November 8, 2023
- 483 · Elegant Direct Corp · November 10, 2021
- 483 · A.M. Surgical, Inc. · October 20, 2023
- 483 · Hill-Rom Services Private Limited · May 10, 2018
- 483 · Oral 7 USA Operations, Inc. · December 9, 2021
- 483 · Temrex Corporation · June 25, 2021
- 483 · LifeSignals Imaging, Inc. · March 11, 2021
- 483 · Dentorium Products Co. Inc. · July 30, 2019
- 483 · Alyk Inc. · May 20, 2022
- 483 · Lingraphicare America, Inc. · August 4, 2022
- 483 · Frostime Llc · October 28, 2020
- 483 · Isomedix Operations, Inc · February 16, 2023
- 483 · LifeSignals Imaging, Inc. · March 11, 2021
- 483 · Edlaw Pharmaceutical, Inc. · November 27, 2019
- 483 · Moss Tubes Inc. · August 13, 2021
- 483 · Please Me LLC · October 28, 2022
- 483 · Medicrea USA Corp · November 21, 2019
- 483 · TruCore Distributors Inc · March 10, 2020
- 483 · Sonomed, Inc. · July 14, 2022
- 483 · Dentaline LLC · July 29, 2021
- 483 · Kem Medical Products Corp · January 15, 2020
- 483 · SM Worldwide USA, Inc. · February 5, 2020
- 483 · Brain Scientific Inc · July 3, 2019
- 483 · 3D Medical Manufacturing, Inc. · September 15, 2022
- 483 · Multigon Industries Inc · February 25, 2022
- 483 · Proactive Medical Products · November 9, 2021
- 483 · Netech Corp. · April 14, 2023
- 483 · Huron Tool & Cutter Grinding Co · July 9, 2021
- 483 · Imediplus Inc. · February 22, 2019
- 483 · Multi-Med, Inc. · September 19, 2024
- 483 · Halo Dream, Inc ( formerly Halo Innovations, Inc.) · November 19, 2021
- 483 · Koios Medical, Inc. · May 13, 2021
- 483 · Ambulatory Monitoring Inc. · February 29, 2024
Frequently inspected with (4)
Person Information
Name
Kwong P. Lee
Title
investigator
Role
COMPANY REP
ID: f4778925-1fad-4988-9e39-86482896c4fa
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