FDA Investigator Nicholas Z Lu

Nicholas Z Lu has inspections in 9 countries as of 13 Nov 2023. Nicholas Z Lu has collaborated with a combinined 3622 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
114
Last Inspection Date:
13 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, New Zealand, China, Malaysia, Taiwan, Mauritius, Thailand, Singapore
Co-Investigator(s):
A Williams, Aaron L Dunbar, Alan M Barker, Alecia L Marson, Amanda Dinaro, Ana L Kewes, Anders W Evenson, Andrew A Leboeuf, Anthony F Lorenzo, Ashley L Reiber, Audrey Dela Cruz, Brian D Nicholson, Brian P Emanuel, Brittani N Franklin, Bruce H Mccullough, Bryan L Mcguckin, Burnell M Henry, Camerson E Moore, Carl A Huffman, III, Carlyn L Ray, Carrie Ann Plucinski, CDR Sean T Creighton, Chad E Schmear, Chad J Whitwell, Charles R Cote, RIC, Chery Grandinetti, Cheryl D Mccall, Christina A Miller, Christopher B Harding, Christopher D Leach, Claire M Minden, Claudette D Brooks, Clifford F Long, Clifton C Francis, Clifton L Randell, Clotia Cabbey Mensah, Constance L Richard, Constance Lrichard Math, Daniel J Lahar, Dariusz Galezowski, Darrell E Luedtke, David E Lowe, David J Gasparovich, David Perkins, Debra I Love, Debra L Boyd Seale, Denise L Burosh, Derek C Price, Don A Leeseberg, Donna Ltartaglino Besone, Dr. Gang Wang, PhD, Dr. Zhou Chen (nmi), MD PhD, Eileen A Liu, Elizabeth D Connell, Elizabeth P Kinsella, Elkins, Emma R Schaefer, Eric M Mueller, PharmD, Eric S Pittman, Fernando C Martinez, Gregory R Dill, Harperd, Herbert M Corbello, Himanshu Gupta, PhD, Inga M Warr, Iris C Macinnes, Jacob W Reynolds, Jacqueline Mdiaz Albertini, James M Odonnell, James W Plucinski, Janae D Price, Janete F Guardia, Janis R Armedoriz, Jasjeet K Sekhon, Jason F Chancey, Jason Weaver, Javelle P Spann, Jeanne J Chiu, Jeanne J Thai, Jeanne M Morris, Jefferey A Hangartner, Jeffery A Hangartner, Jeffry A Bernhardt, Jennifer A D'angelo, Jennifer C Johnson, Jesse A Vazquez, Jocelyn C Turner, John M Seale, John P Hermann, Jonathan R Campos, Joseph A Morkunas, Joseph A Piechocki, Joshua J Silvestri, Juanelma H Palmer, Jude C Dikes, Justin A Boyd, Karen Emasley Joseph, Kathleen B Swat, Kathleen S Tormey, Kenneth S Boehnen, Kimberly Lewandowski Walker, Kwong P Lee, Kyran R Gibson, Lareese K Thomas, Larry F Hallberg, Latoya A Griffith, Lauren A Crivellone, Lauren N Howard, Leeterry Moore, Lequita M Mayhew, Leslie D Hintz, Linda F Murphy, Lisa Hornback, Lisa T Michel, Lorelei S Jarrell, Makini Cobourne Duval, PhD, Maksim A Levenchuk, Margaret Torres Vazquez, Marissa S Steinhagen, Mark E Frank, Mark I Kaspar, Marvin D Jones, Mary A Millner, Mary L Schuckmann, Matthew J Sienko, Melanie W Pishnery, Melissa J Holz, Melissa J Ireland, Michael K Larson, Michele L Glendenning, Michele Perry Williams, Michelle J Glembin, Mohsen Rajabi Abhari, FDA, Natasha R Johnson, Nibin Varghese, MS, Nicholas P Diorio, Nicholas T Domer, Nicole J Clausen, Nicole S Williams, Norman K Starks, Norman Wong, Pablo Alcantara, Paola S Barnett, Patricia A Mcilroy, Paul L Bellamy, Paula P Demichael, Perry H Gambrell, Phung Thien Nguyen, Prabhu P Raju, Pradip N Akolkar, Quynh H Strandberg, Rachel T Evans, Rafael A Kaup, Rafael Padilla, Ralph Jerndal, Richard Jay Tucker, RS, Richard L Mallonee, Robert J Ham, Roberta W Cunningham, Rose M Ashley, Rosemary A Sexton, Roy Baby, Russell K Riley, Ryan S Martin, Samantha J Bradley, Samuel L Murray, Sandra A Hughes, Sarah A Palmer, Sarah E Rhoades, Sarah Nwandiuko, Scott B Laufenberg, Shafiq S Ahadi, Shalonda C Clifford, Sherea L Dillon, Simone E Pitts, State Agency, Stephen D Eich, Steven R Ziser, Sullan, Sumit Sen, Susan D Yuscius, Susan O Oladeji, Susan P Bruederle, Susan Yuscius, Tamara Brey, Tenzin Jangchup, Thai T Duong, That Q Dang, Thunder N Dunkijacobs, Todd M Stankewicz, Todd Q Dang, Ulysses D Singleton, Veronica Fuentes, MS, Vioela J Caze, Vivian Garcia, Vivin George, Vladimir Wolf, Wanda B Coats, William R Weissinger, Yiyue Zhang (nmi), PhD, Yuanyuan Li, Yvonne E Lozano

Nicholas Z Lu's Documents

Publish Date Document Type Title
February, 2022 FDA 483 Bradshaw Medical, Inc. - Form 483, 2022-02-28
March, 2019 FDA 483 Preservation Solutions, Inc. - Form 483, 2019-03-12
April, 2019 FDA 483 SurgiTools (Shanghai) Medical Instruments Co., Ltd. - Form 483, 2019-04-17
October, 2019 FDA 483 Medegen Medical Products, LLC - Form 483, 2019-10-10
June, 2019 FDA 483 Emilia Resources, LLC - Form 483, 2019-06-18
July, 2022 FDA 483 DENTAL TECHNOLOGIES, INC. - Form 483, 2022-07-26
October, 2017 FDA 483 Barrington Ventures, Ltd - Form 483, 2017-10-19
July, 2022 FDA 483 Cytophil, Inc. - Form 483, 2022-07-29
September, 2022 FDA 483 Oak Ridge Products - Form 483, 2022-09-30
June, 2019 FDA 483 Zavation - Form 483, 2019-06-20
October, 2021 FDA 483 Luminex Corporation - Form 483, 2021-10-22
November, 2021 FDA 483 Quadrant Technologies, LLC - Form 483, 2021-11-30
May, 2019 FDA 483 Ashlar Medical LLC - Form 483, 2019-05-09
January, 2020 FDA 483 EPS Bio Technology Corp. - Form 483, 2020-01-08
January, 2023 FDA 483 Response Luminex Corporation - Form 483R, 2023-02-10
June, 2017 FDA 483 X-Cel X-Ray Corp - Form 483, 2017-06-23
September, 2018 FDA 483 Myerson LLC - Form 483, 2018-09-28
November, 2022 FDA 483 Digital Diagnostics Inc. - Form 483, 2022-11-10
April, 2018 FDA 483 Blue Sky Bio, LLC - Form 483, 2018-04-27
August, 2023 FDA 483 Baxter Healthcare Corporation - Form 483, 2023-08-18
November, 2017 EIR Medical Murray Inc. - EIR, 2017-11-15
January, 2023 FDA 483 Luminex Corporation - Form 483, 2023-01-20
September, 2017 FDA 483 Tetra Medical Supply Corp. - Form 483, 2017-09-28
March, 2023 EIR Eli Lilly and Company - EIR, 2023-03-16
February, 2020 FDA 483 Luminex Corporation - Form 483, 2020-02-14
December, 2017 FDA 483 Alpha Tekniko - Form 483, 2017-12-14
September, 2017 FDA 483 Ad-Tech Medical Instrument Corporation - Form 483, 2017-09-05
March, 2021 FDA 483 Healthlight LLC - Form 483, 2021-03-11
April, 2019 FDA 483 Won Industry Co. LTD - Form 483, 2019-04-11
August, 2018 FDA 483 Response Becton Dickinson Medical Systems - Form 483R, 2018-08-21
March, 2020 FDA 483 Richard Wolf Medical Instruments Corp. - Form 483, 2020-03-18
September, 2021 FDA 483 Preservation Solutions, Inc. - Form 483, 2021-09-30
March, 2022 FDA 483 Astron Dental Corp - Form 483, 2022-03-18
October, 2017 FDA 483 Oak Ridge Products - Form 483, 2017-10-26
January, 2023 EIR Luminex Corporation - EIR, 2023-01-20
August, 2018 FDA 483 Becton Dickinson Medical Systems - Form 483, 2018-08-01
February, 2022 FDA 483 Circuit Works Corporation - Form 483, 2022-02-15
February, 2020 EIR Sterigenics U.S., LLC - EIR, 2020-02-25
February, 2019 FDA 483 Electro Kinetic Technologies, LLC - Form 483, 2019-02-15
October, 2018 FDA 483 Cortek Endoscopy Inc - Form 483, 2018-10-16
July, 2019 FDA 483 Custom Assemblies, Inc. - Form 483, 2019-07-19
February, 2023 FDA 483 Uberlube, Inc. - Form 483, 2023-02-16
October, 2022 FDA 483 Patrin Pharma, Inc - Form 483, 2022-10-18
January, 2018 FDA 483 Weiman Products, LLC - Form 483, 2018-01-10
January, 2018 FDA 483 Waldmann Lighting Co - Form 483, 2018-01-17
August, 2018 FDA 483 Preservation Solutions, Inc. - Form 483, 2018-08-10
March, 2018 EIR Stradis Healthcare - EIR, 2018-03-22
January, 2023 FDA 483 Luminex Corporation - Form 483, 2023-01-19
April, 2023 FDA 483 PPD Development, L.P. - Form 483, 2023-04-05
August, 2019 FDA 483 Bemis Manufacturing Co. - Form 483, 2019-08-14
September, 2021 FDA 483 Response Preservation Solutions, Inc. - Form 483R, 2021-10-26
August, 2019 FDA 483 Zetta Medical Technologies, LLC - Form 483, 2019-08-27
April, 2022 FDA 483 MEDLINE INDUSTRIES, LP - Northfield - Form 483, 2022-04-06
November, 2023 FDA 483 Amsino Healthcare (USA) Inc. - Form 483, 2023-11-13

Experience Redica System's NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more