FDA Person
FDANicholas Z. Lu
View detailed information about Nicholas Z. Lu, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 111 inspections of 103 companies, 2017–2025.
Inspections (111)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| March 26, 2025 | BQ PLUS MEDICAL CO,.LTD | NAI | Compliance: Devices | #1271555 |
| March 19, 2025 | Hangzhou Jinlin Medical Appliances Co., Ltd. | NAI | Compliance: Devices | #1271610 |
| March 12, 2025 | Infus Medical (Thailand) Co.,Ltd. | NAI | Compliance: Devices | #1265738 |
| February 27, 2025 | Dimension Inx Corp. | NAI | Postmarket Assurance: Medical Devices | #1262143 |
| February 11, 2025 | NAI | Compliance: Devices | #1261730 | |
| February 11, 2025 | Metritrack Inc | Not classified | #1261730 | |
| January 30, 2025 | Amsino Healthcare (USA) Inc | OAI | Compliance: Devices | #1261291 |
| January 8, 2025 | Grant Technologies LLC | Not classified | #1258390 | |
| December 18, 2024 | Norfolk Medical Products, Inc. | NAI | Compliance: Devices | #1257901 |
| December 17, 2024 | Sterigenics U.S., LLC | NAI | Postmarket Assurance: Medical Devices | #1256890 |
| December 10, 2024 | Atrility Medical, Inc. | NAI | Compliance: Devices | #1256772 |
| November 21, 2024 | Granite Microsystems, Inc. | VAI | Compliance: Medical Devices | #1254710 |
| November 7, 2024 | Commercial Plastics Kenosha LLC | NAI | Postmarket Assurance: Medical Devices | #1253941 |
| September 23, 2024 | Isomedix Operations, Inc. | NAI | Postmarket Assurance: Devices | #1250815 |
| September 19, 2024 | Isomedix Operations, Inc. | Not classified | #1250741 | |
| September 12, 2024 | Micro Precision Swiss, LLC | NAI | Postmarket Assurance: Medical Devices | #1249107 |
| September 3, 2024 | Dental Health Associates Of Madison, Ltd | Not classified | #1248240 | |
| August 14, 2024 | Dental Technologies Inc. | VAI | Compliance: Devices | #1240761 |
| July 11, 2024 | Axcesor, Inc. | NAI | Compliance: Devices | #1244215 |
| June 25, 2024 | Exact Sciences Corp | NAI | Compliance: Devices | #1229639 |
Documents (47)
- 483 · Granite Microsystems, Inc. · November 21, 2024
- EIR · Granite Microsystems, Inc. · November 21, 2024
- EIR · Luminex Corporation · January 20, 2023
- 483 · Amsino Healthcare (USA) Inc · January 30, 2025
- 483 · Preservation Solutions, Inc. · July 14, 2023
- 483 · Healthlight LLC · March 11, 2021
- 483 · Becton Dickinson Medical Systems · August 1, 2018
- 483 · Amsino Healthcare (USA) Inc · November 13, 2023
- 483 · Oak Ridge Products · September 30, 2022
- EIR · Stradis Healthcare · March 22, 2018
- 483 · Luminex Corporation · January 13, 2023
- 483 · Micro Precision Swiss, LLC · September 12, 2024
- 483 · Dimension Inx Corp. · February 27, 2025
- 483 · Sterigenics U.S., LLC · December 17, 2024
- 483 · Commercial Plastics Kenosha LLC · November 7, 2024
- 483 · Dental Health Associates Of Madison, Ltd · September 3, 2024
- 483 · Medegen Medical Products, LLC · October 10, 2019
- 483 · Luminex Corporation · October 22, 2021
- 483 · Ashlar Medical LLC · May 9, 2019
- 483 · Cytophil, Inc. · July 29, 2022
- 483 · MEDLINE INDUSTRIES, LP - Northfield · April 6, 2022
- 483 · Emilia Resources, LLC · June 18, 2019
- 483 · Preservation Solutions, Inc. · September 30, 2021
- 483 · Bradshaw Medical, Inc. · February 28, 2022
- 483 · Electro Kinetic Technologies, LLC · February 15, 2019
- 483 · Agiliti Health Inc. · August 27, 2019
- 483 · Uberlube, Inc. · February 16, 2023
- 483 · Bemis Manufacturing Co. · August 14, 2019
- 483 · Bemis Manufacturing Co. · August 14, 2019
- 483 · Zavation · June 20, 2019
- 483 · Won Industry Co. LTD · April 11, 2019
- 483 · Digital Diagnostics Inc. · November 10, 2022
- 483 · Baxter Healthcare Corporation · August 18, 2023
- 483 · Optikem International, Inc. · March 1, 2024
- 483 · Richard Wolf Medical Instruments Corp. · March 18, 2020
- 483 · PPD Development, L.P. · April 5, 2023
- 483 · Astron Dental Corp · March 18, 2022
- 483 · Circuit Works Corporation · February 15, 2022
- 483 · Dental Technologies Inc.
- 483 · Luminex Corporation · February 14, 2020
- 483 · Patrin Pharma, Inc. · October 18, 2022
- 483 · Surgitools Pty Ltd · April 17, 2019
- 483 · Custom Assemblies, Inc. · July 19, 2019
- 483 · Luminex Corporation · January 20, 2023
- 483 · Amsino Healthcare (USA) Inc. · January 30, 2025
- 483 · PPD Development, L.P. · April 5, 2023
- EIR · Medical Murray Inc. · November 15, 2017
Frequently inspected with (10)
Stephen D. Eich
investigator
9 shared
Shawn Choi
3 shared
Anders W. Evenson
2 shared
Chad E. Schmear
2 shared
Joohi Castelvetere
2 shared
Michelle J. Glembin
investigator
2 shared
Nicholas T. Domer
investigator
2 shared
Audrey A. De La Cruz
1 shared
Brittani N. Franklin
1 shared
Christopher D. Leach
Compliance Officer at FDA
1 shared
Person Information
Name
Nicholas Z. Lu
Role
ISSUING OFFICER
ID: 17448aca-e316-424c-b7b2-88c8baffc359
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