FDA Investigator Lakecha N Lewis

Lakecha N Lewis has conducted inspections on 246 sites in 22 countries as of 20 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
246
Last Inspection Date:
20 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Poland, Peru, India, Canada, Ireland, Italy, Taiwan, China, Romania, Germany, Bulgaria, France, Korea (Republic of), United Kingdom of Great Britain and Northern Ireland, Denmark, Colombia, Belgium, Netherlands, South Africa, Spain, Finland
FDA Investigators that have inspected at least one site in common with Lakecha N Lewis:
Alan M Stevens, Aleta T Flores, Alexandra B Pitkin, Allen F Hall, Althea A Williams, Amanda L Fyles, Amir Alavi, Ana Djurdjevic, Anastasia I Onuorah, Andrea A Branche, Andrew J Gonzales, Andy B Lee, Angela Shepas, Angelica G Aziz, Anna J Vickrey, Armando Chavez, MS, Arsen Karapetyan, Ashar P Parikh, Avery J Dennis, Bailey A Uetrecht, Barbara J Rincon, Bichsa T Tran, Binh T Nguyen, Blondell W Johnson, Bonita S Chester, Bonnie I Needleman, Brian P Putz, Brian R Cronenwett, Brian Ravitch, Bruce W Benware, Bryan A Galvez, Bryce A May, Burnsb, Bush, Byungja E Marciante, Cara L Alfaro, Carla J Lundi, Carla R Hinz, Carlos Chavez, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Cathleen A Carr Sharpe, Cathryn M Groehnert, Celena Ngo, Cesar A Herrera, Charles L Larson, Cheron M Portee, Cheryl D Mccall, Christina D Mello, Ciara J Bajulai Austin, Claudia Mperez Kasmarski, Comyar Shoghi, Connie Ng, Craig A Garmendia, Crystal Monroy, Cynthia F Kleppinger, MD, Daniel J Munoz, Darren S Brown, Darrin E Davis, David G Whitman, David Serrano, David Y Hernandez, Davis, Dawn C Olenjack, Daynia L Lashaway, Deborah A Greco, Deborah K Richardson, Debra C Yamane, Debra J Fracassa, Dejon N Harris, Denise L Burosh, Dennis Cantellops Paite, Dennis G Poertner, Derek S Dealy, Desiree C Iya, Diana L Ayala, Diana M Rand, Diane Cvan Leeuwen, Dipesh K Shah, Dogbeda F Mackenzie, Dolores Harper, Donna Ltartaglino Besone, Doretha M Wilson, Dr. Chunchang Fang, Dr. Gopa Biswas, PhD, Duc Minh H Nguyen, Durell L Giles, Dyana K Stone, Dylan R Jock, Edith M Gonzalez, Eileen J Bannerman, Eileen T Dupont, Eileen T Monaghan, Elizabeth A Dakan, Elizabeth Ad Girard, Elizabeth M Dahl, Ellen N Stewart, Erica R Woody, Esther B Gamallo Herrera, Ethan P Stegman, Francisco, Frederick L Fricke, Gam S Zamil, Garciam, Garrad R Poole, Gary R Wong, Gene D Arcy, Geoffrey K Kilili, Geoffrey M Leist, Geraldine M Peregrin, Gordon Chu, Grace P Santos, Greg K Keshishyan, Guerlain Ulysse, Guo Q Shen, Hagstrom, Hasan A Irier, PhD, Heidy C Perales, Henry E Carrillo, Herminio C Francisco, Himanshu Gupta, PhD, Homero W Aguilar, Hossein Khorshidi, PhD, Hugh A Grimoldby, Ian A Pilcher, Indigo A Doll, Ingrid A Zambrana, Iris C Macinnes, Ivar J Sohn, Jacob W Reynolds, Jai P Singh, James A Barreto, James B Arnett, James C Maclaughlin, James E Trabert, James P Mcevoy, James P Stallings, James R Fleckenstein, Jamie M Du, Janet Pulver, Janete F Guardia, Janice M Loy, Jazmine M Welcher, Jeannie Pradyanata, Jeff M Uriarte, Jeffrey P Raimondi, Jennie J Fan, Jennifer C Adams, Jennifer M Gogley, Jennifer M Pouget, Jeremy Beber, Jessica L Andrade, Jessica M Ector, Jin M Kim, Jinnie Kokiatkulkij, Jocelyn E Massey, Joe X Phillips, Joel D Martinez, Joey V Quitania, John A Daubenspeck, John A Gonzalez, John A Iwen, John A Liu, Jolanna A Norton, Jose A Lopez, Joseph C Yen, Joseph M Allen, Joseph X Phillips, Juanita Banuelos, Judy C Nepsa, Julian C Hanson, Ka L Wong, Kaitlyn T Dang, Kara A Scheibner, PhD, Karen A Wolnik, Karen M Cooper, Karen M Gasperic, Karen M Montgomery (KMM), Kari M Johansen, Katherine E Jacobitz, Kathryn A Krentz, Kathy Kuo, Keeshunna D Daniels, Kelley, Kelvin Cheung, Kelvin X Sanders, Kenneth S Boehnen, Kevin Lee, Kevin N Tran, Kevin T Gerrity, Kham Phommachanh, Kim Lthomas Cruse, Kimberly M Lichter, Kirsten S Tharp, Kirtida Patel, Kouros Kangarli, Kristen E Szenderski, Kristin M Abaonza, Kyson X Chou, Lanita F Kelley, Laura A Munsterman, Lauren E Swantko, Laurissa S Flowers, Lavender M Huskey, LCDR Wilfred A Darang, Leonard H Lavi, Lester O Boian, Leticia I Romero, Libia M Lugo, Lillian S Wu, Lilly O Barton, Liming Zhang, Lin Liu, Linda Thai, Ling Yu L Liu, Lisa K Capron, Lisa Shin, Loretta J Miller, Lori A Gioia, Mageet, Marcia A Worley, Marcus D Fairconnetue, Marcus F Yambot, Margo C Jones, Marie Falcone, Marie T Falcone, Marilyn S Babu, Mark C Saale, Mark W Babbitt, Mary T Carden, Matthew J Gretkierewicz, Matthew M Vernon, Maxyne T Lam, Mei Chen Mu, Mendoza O Wallace, Michael D Garcia, Michael S Araneta, Michael S Call, Michael T Cyrus, Michele B Fedowitz, Michelle J Hines, Min Lu, Minh D Phan, Mohsen Rajabi Abhari, FDA, Natalie J Ayoub, Naveen B Walker, Ni Aye Khin, MD, Nianna C Burns, Nianna M Capalia, Nicholas L Hunt, Nicole C Victoria, PhD, Nicole Zugsmith, Pamela Y Lee, Patricia F Alberico, Perry H Gambrell, Peter C Chow, Phal K Chhun, Philip F Istafanos, DMV, MS, Phillip D Kronstein, MD, Phillip J Sample, Phillip L Toy, Rachel C Stanton, Ramon A Hernandez, Raymond W Brullo, Rebecca T Davis, Richard G Fochesato, Richard W Berning, Richard W Tubb, Robert C Coleman, Robert C Hoover, Rochelle A Rolnik, Rocio Guzman Velazquez, Romero, Ronald L Koller, Ronda Rloyd Jones, Ruben C Ayala, PharmD, Ryan J Borges, Samson O Oluseye, Samuel Rudnitsky, Sandra A Boyd, Sandra A Hughes, Sara E Cooley, Sara H Gabel, Sara Jdent Acosta, Sarah A Hassas, Sarah Forney, Scott B Laufenberg, Scott K Zika, Sean P Desbrow, Selene T Torres, Shaquenta Y Perkins, Sharon S Ho, Shelley H Beausoleil, Sheri S Oliver, Sherri J Jackson, Sherri N Rohlf, MD, Sonya L Karsik, RAC, Sparky L Bartee, Srinivas R Chennamaneni, PhD, Stacie A Woods, Stephanie A Slater, MS, Stephen R Souza, Steven E Porter, Jr, Sue Lee Chan, Sundy V Sedwick, Sunitha K Rajaram, PhD, Susan D Yuscius, Susanna E Ford, Susanna N Choi, Taichun Qin, PhD, Tamala P Bogan, Tamala P Magee, Tamara L Alexander, Tammy Vasquez Hancock, Tanya L Keigley, Tara G Bizjak, Tawny L Colling, Terrance L Thomas, Terrance P Nguyen, Thanh B Tran, Thanh M Andrews, Thao T Kwan, Thea C Grome, Theresa Kirkham (NMI), Theressa B Smith, Thomas R Beilke, Tiara Nbrown Crosen, Timothy P Lafave, Tonia L Sawyer, Tony J Wu, Tracey T Duong, Traci B Bickell, Triet M Tran, Trudy R Papson, Truong Xuan Nguyen (Andy), Trushani T Desai, Uttaniti Limchumroon (Tom), Valerie L Whipp, Vanessa R Muller, Vashti E Bocker, Vien Q Le, Virgilio F Pacio, CSO, Walden H Lee, Wayne L Jefferson, Wenzheng Wendy Zhang, Wr Bowman, Xiaohui Shen, Yangmin Ning, Yumi J Hiramine, Yvette Mlacour Davis, Yvonne C Wilkes, Yvonne T Lacour, Yvonne Y Wu, Zachary A Bogorad, Zerita White

Lakecha N Lewis's Documents

Publish Date Document Type Title
March, 2011 FDA 483 WR Cramer - Form 483, 2011-03-24
August, 2011 FDA 483 Windsor Quality Foods Co - Form 483, 2011-08-25
September, 2017 FDA 483 Bernard A Michlin, MD - Form 483, 2017-09-01
April, 2023 FDA 483 Maxwell B. Sauder, M.D. - Form 483, 2023-04-06
June, 2018 FDA 483 Sudhir Gupta, M.D., Ph.D., M.A.C.P - Form 483, 2018-06-11
March, 2014 EIR John W. McGettigan, Jr., M.D. - EIR, 2014-03-12
July, 2010 FDA 483 Kenwick, Inc. - Form 483, 2010-07-30
August, 2017 EIR Salem, Galal M.D. - EIR, 2017-08-25
October, 2018 FDA 483 Terry W. Chin, M.D. - Form 483, 2018-10-16
June, 2011 FDA 483 Green Pharmaceuticals, Inc. - Form 483, 2011-06-30
March, 2019 EIR Kareway Product Inc - EIR, 2019-03-28
August, 2023 FDA 483 MARKSANS PHARMA LIMITED - Form 483, 2023-08-04
February, 2016 FDA 483 Response Acadia Pharmaceuticals Inc. - Form 483R, 2016-03-02
November, 2017 EIR Intertek USA, Inc. - EIR, 2017-11-09
August, 2019 FDA 483 Thomas D. Coates, M.D. - Form 483, 2019-08-02
April, 2013 EIR SPECTRUM LABORATORY PRODUCTS INC. dba SPECTRUM CHEMICAL MFG. CORP. - EIR, 2013-04-23
January, 2021 FDA 483 Acadia Pharmaceuticals Inc. - Form 483, 2021-01-27
September, 2018 FDA 483 Response Odonate Therapeutics LLC - Form 483R, 2018-09-28
April, 2012 FDA 483 Huy Fong Foods, Inc - Form 483, 2012-04-13
August, 2019 EIR Brian B. Siu, M.D., Ph.D. - EIR, 2019-08-22
May, 2022 FDA 483 Elena Vassilev, DVM, DACVECC - Form 483, 2022-05-19
July, 2016 FDA 483 Medtronic MiniMed, Inc. - Form 483, 2016-07-22
February, 2018 FDA 483 Eli Engel, M.D. - Form 483, 2018-02-06
November, 2017 FDA 483 Intertek USA, Inc. - Form 483, 2017-11-09
September, 2013 EIR Omid Hamid, M.D. - EIR, 2013-09-30
January, 2020 FDA 483 Marina Nikanorova, M.D. - Form 483, 2020-01-24
October, 2023 FDA 483 Nobles Medical Technology, II - Form 483, 2023-10-20
July, 2016 EIR Medtronic MiniMed, Inc. - EIR, 2016-07-22
September, 2018 FDA 483 Odonate Therapeutics LLC - Form 483, 2018-09-11
December, 2022 FDA 483 Asen Georgiev Medzhidiev - Form 483, 2022-12-16
January, 2021 FDA 483 Response Acadia Pharmaceuticals Inc. - Form 483R, 2021-02-11
March, 2019 FDA 483 Kareway Product Inc - Form 483, 2019-03-28
November, 2020 FDA 483 Ronald B. Natale, MD - Form 483, 2020-11-13
February, 2016 EIR Acadia Pharmaceuticals Inc. - EIR, 2016-02-17
September, 2017 EIR Bernard A Michlin, MD - EIR, 2017-09-01
March, 2014 FDA 483 John W. McGettigan, Jr., M.D. - Form 483, 2014-03-12
August, 2017 FDA 483 Salem, Galal M.D. - Form 483, 2017-08-25
June, 2019 FDA 483 Samm Solutions, Inc (dba) BTS Research - Form 483, 2019-06-21
May, 2011 FDA 483 David M. Stoll, MD - Form 483, 2011-05-09
January, 2019 FDA 483 Dr. Gerald Ho, MD - Form 483, 2019-01-30

Experience Redica Systems’ 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