FDA Investigator Michael Shanks, MS

Michael Shanks, MS has inspections in 16 countries as of 11 Oct 2023. Michael Shanks, MS has collaborated with a combinined 10624 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
61
Last Inspection Date:
11 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
Germany, India, China, Korea (Republic of), Slovenia, United States of America, Japan, Italy, Switzerland, Denmark, Ireland, Austria, Israel, South Africa, Poland
Co-Investigator(s):
Adaliz Santaliz Cruz, Alan A Rivera, Alan L Truong, Alanna Lmussawwir Bias, Alberto A Viciedo, Alexandra B Pitkin, Alexey Khrenov, PhD, Alice S Tsao, Alicia M Mozzachio, Alison N Stieg, Amanda L Fyles, Amir Alavi, Amy C Jordan, Amy Devlin, PhD, Amy Hsu, PhD, Amy N Chen, Amy S Graf, Anastasia G Lolas, Andrace Lde Yampert, Andrea A Branche, Andrea D Swingle, Andrea Franco, Andrea George, PhD, Andrea Siegel, PhD, Andrew J Barrowcliff, Angel K Sandhu, Angela E Glenn, Anh M Lac, Anita Narula, PhD, Anjali Shukla, PhD, Ann L Demarco, Ann Marie Montemurro, Anthony F Lorenzo, April L Young, Ariel Cruz Figueroa, Arlene M Badillo, Arsen Karapetyan, Art O Czabaniuk, Arthur S Williams, Jr, Arulvathani P Arudchandran, Ashley N Queen, PhD, Ashutosh Rao, PhD, Azza Talaat, Babajide Michael Osunsanmi, Barbara A Gullick, Barbara J Wilcox, PhD, Barbara Janine Breithaupt, Bei Y He, Benjamin J Smith, Bijoy Panicher, Bijoy Panicker, Binh T Nguyen, Bo Chi, PhD, Brandon C Heitmeier, Brandy N Lepage, Brenda W Uratani, PhD, Brian A Roelofs, Brian D Nicholson, Brian M Janelsins, PhD, Brooke K Higgins, Bruce H Mccullough, Bryan A Galvez, Byungja E Marciante, Calvin B Koerner, Candace Y Gomez Broughton, Carl A Huffman, III, Carl Lee, Carla J Lundi, Carole L Jones, Carr Sharpe, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, CDR Donald Ertel, Chaltu N Wakijra, Charanjeet Jassal, Charles I Ann, Charles L Zhou, Charles M Edwards, Chen Sun, PhD, Cheryl A Clausen, Chiang Syin, PhD, Chikako Torgioe, Christian D Lynch (CDL), Christina K Theodorou, Christopher D Leach, Christopher Downey, PhD, Christopher R Czajka, Claudia Mperez Kasmarski, Colleen Thomas, PhD, Constantin Y Philopoulos, Corrine M Carter, Cristina Ausin Moreno, PhD, Cristina Ausin Moreoo, PhD, Cynthia Jim, CSO, Daniel J Brown, Daniel J Lahar, Daniel J Roberts, Daryl A Dewoskin, David A Oluwo, David A Paterson, David G Eng, David G Whitman, David J Gomes, David M Beltran, Davinna Ligons, PhD, Debara R Reese, Debara Reese, Deborah M Trout, Deborah Schmiel, PhD, Dell S Moller, Denise L Burosh, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Deyaa Shaheen, Diane L Raccasi, Dien N Nguyen, Dilip Devineni, PhD, Dina A Tallman, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Don H Bark, PhD, Donald C Obenhuber, PhD, Donald H Barks, Donna Ltartaglino Besone, Douglas A Campbell, Dov Pluznik, PhD, Dr. Barbara D Paul, PhD, Dr. Dominick Roselle, Dr. Jun Liu, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Roslyn F Powers, Dr. Yubing Tang, Dustin R Abaonza, Eboni S Funderburk, Edmund F Mrak, Jr, Edwin Jao, Eileen A Liu, Eliezar Ramos, Emest F Bizjak, Emilie E Kahn, Emily J Orban, Emily Shacter, Ephrem Hunde, PhD, Eric L Dong, BS, Eric M Mueller, PharmD, Erik W Koester, Erika V Butler, Erin D Mccaffery, Erk W Koester, Esther C Broner, PhD, Evelyn Wong, Felix Maldonado, Frances Namuswe, PhD, Francis A Guidry, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Gerald Feldman, Gerald M Feldman, PhD, Grace Deneke, Graeme E Price, Gwyn G Dickinson, Hector J Colon Torres, Helen B Ricalde, Henry K Lau, Henry X Lau, Herbert M Corbello, Hyung Yul Lee, Ian L Mcwilliams, Ian Mcwilliams, Ivis L Negrón, Ivis Lnegron Torres, Jacek Cieslak, PhD, Jacob G Lutz, Jacqueline Mdiaz Albertini, James A Lane, James C Maclaughlin, James D Bridges, James I Giefer, James L Dunnie, Jr, James M Mason, James M Simpson, James R Evans, Javier E Santos, Jean Blackston Hill, Jean Blackstone Hill, Jeanne Fringer, PhD, Jee Chung, PhD, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer A Kemp, Jennifer C Adams, Jennifer Lalama, Jennifer M Gogley, Jennifer Swisher, PhD, Jerri Baker, Jessica Hankins, PhD, Jessica L Pressley, Jing Fang, Joan T Briones, Joel D Martinez, Joey V Quitania, John D White, Jolanna A Norton, Jon P Antoniou, Jonah S Ufferfilge, Jonah Ufferfilge, Jonathan W Chapman, Joohi Castelvetere, Jorge L Guadalupe, Jorge L Lajara, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose R Lopez, Jose Velez, Joseph A Piechocki, Joseph Kutze, PhD, Joseph P Iser, MD, Joseph R Lambert, Joseph R Strelnik, Joseph T Madak, Joseph W Matthews, Joshua S Hunt, Joslyn K Brunelle, PhD, Juhong Liu, PhD, Julie D Bringger, Junho Pak, Justin A Boyd, Justine Tomasso, Kalavati Suvarna, PhD, Karen A Briggs, Karen M Montgomery (KMM), Kari M Johansen, Katherine E Jacobitz, Katherine Szestypalow, Kathleen M Jordan, Kathleen R Jones, PhD, Kathy Chiu, Kathy E Craven, Kathy E Noe, Kathy Lee, Kelley, Kelvin Cheung, Kenneth Gordon, Kenneth M Gordon, Kenneth Nieves, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kim Lthomas Cruse, Kimberly Lewandowski Walker, Ko U Min, Kristen Nickens, PhD, Kristina L Conroy, Kshitij A Patkar, Kurt A Brorson, PhD, L'oreal F Walker, Lakisha M Williams, Lakshmi Narasimhan, PhD, Lance M De Souza, MBA, Larry K Austin, Lata C Mathew, PhD, Laura Fontan, MS, Laureen F Kononen, Laurel A Beer, Lauren Iacono Connors, PhD, Lauren M Lilly, PhD, Lauren N Barber, Laurie Graham, Laurie Nelson, Laurie P Norwood, Lawrence Harmon, Jr, Lawrence J Stringer, LCDR Jennifer H Rhyu, LCDR Sean Byrd, Lei Zhang, PhD, Leigh Anne Myers, Leiyun Boone, PhD, Leslie Arivera Rosado, PhD, Lestine C Webb, Libia M Lugo, Linda F Murphy, Linda Thai, Lindsey Brown, PhD, Lindsey S Fleischman, Linh Tu, Liqun Zhao, Lisa M Bellows, Logan T Williams, Lori S Lawless, Lorie S Hannappel, LT Rafael Gonzalez, LT Richard A Lyght, Lucila B Nwatu, Luella J Rossi, Luis A Dasta, Mabel M Lee, Madushini Dharmasena, PhD, Maida Henesian (NMI), Marc S Neubauer, Marcellinus D Dordunoo, Marcus A Ray, Marcus F Yambot, Margaret M Annes, Margaret M Doherty, Margaret M Sands, Margarita Santiago, Maria Cecilia Tami, PhD, Maria Cruz Fisher, Maria G Gutierrez Hoffman, Maria Gutierrez Lugo, PhD, Maria I Cruz Fisher, Maria Joselopez Barragan, PhD, Marian E Ramirez, Marie K Kinkade, Marion Michaelis, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark Brunswick, PhD, Mark D Johnson, Mark R Mcclain, Marlene G Swider, Marsha W Major, Mary E Farbman, PhD, Mary E Storch, Maryam Tabatabaie, Massod Rahimi, PhD, Matt D Suedkamp, Matthew B Casale, Matthew D Schnittker, Matthew M Henciak, Maxwell Van Tassell, PhD, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melina Rodriguez Upton, Melissa D Ray, Melissa J Garcia, Mercy Oyugi, Meredith P Soehl, Investigator, Merry Christie, PhD, Miah I Schneider, Michael A Charles, Michael E Maselli, Michael P Sheehan, Michael R Klapal, Michael T Cyrus, Michele L Forster, PhD, Michele L Obert, Michele Perry Williams, Michelle Rfrazier Jessen, PhD, Michelle Y Clark Stuart, Miguel A Martinez, Mihaly S Ligmond, Milos Dokmanovic, PhD, Milva E Melendez, Milva Emelendez Perales, Min Shanma Liu, Mindy M Chou, Mizanne E Lewis, Monica Commerford, PhD, Monica Markovski, PhD, Monika Borkowska, Montgomery Montgomery, Karen M, Mra B Kamberem, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Muna Algharibeh, Muna Alghribeh, Muralidhara B Gavini, PhD, Myra K Casey, Myriam M Sosa, Nadeem I Chaudhry, Nailing Zhang, Nayan J Patel, Nayan Patel, Neal L Adams, Neali H Lucas, Nealie C Newberger, Nebil A Oumer, Nicholas A Violand, Nicholas L Paulin, Nicholas Obiri, PhD, Nikolay Spiridonov, Nirjal Bhattarai, Noreen Muniz, Noreen Muñiz, Nydia E Colon, Omotunde O Osunsanmi, Patricia A Cochran, Patricia Fhughes Troost, Patricia H Dlugosz, Patrick B Cummings, Patrick C Klotzbuecher, Patrick J Lynch, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul E Stein, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Paul R Whitby, Paul Z Balcer, Paula A Trost, Peter Adams, PhD, Peter E Baker, Peter Kessler, PhD, Phillip Angart, PhD, Prabhu P Raju, Qiao Y Bobo, Qing Joanna Zhou, PhD, Rabia Ballica, PhD, Rachael O Oyewole, Rachael Oyewole, Rachel C Harrington, Rafael Padilla, Rafeeq A Habeeb, Ralph H Vocque, Ralph Jerndal, Ramesh Potla, PhD, Ramon A Hernandez, Rashmi Rawat, PhD, Raymond T Oji, Reba A Gates, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Parrilla, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Reyes Candau Chacon, PhD, Richard K Vogel, Richard Ledwidge (nmi), PhD, Richard W Berning, Riley C Myers, PhD, Robert Barbosa, Robert C Coleman, Robert D Tollefsen, Robert Darius, Robert H Wittorf, Robert J Ham, Robert J Martin, Robert M Barbosa, Robert Rodriguez, Robert W Jennings, Rodney D Combs, Rosanna M Goodrich, Rose M Ashley, Roy C Stephens, Roy R Rinc, Russell J Glapion, Russell K Riley, Ruth Moore, PhD, S Lori Brown, PhD MPH, Saied A Asbagh, Salvatore N Randazzo, Salwa K Poole, Samina S Khan, Samuel K Gibbons, Jr, Sandra A Boyd, Sandra A Hughes, Sandra S Saniga, Sangeeta M Khurana, PhD, Sanket N Patel, Santiago Gallardo Johnson, Santos E Camara, Sarah Arden, Sarah E Rhoades, Sarah Kennett, PhD, Sarah M Meng, Sarah M Napier, Sargum C Sood, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sean P Desbrow, Sean R Bryd, Sean R Marcsisin, Seneca D Toms, Serge Beaucage, Shadia Zaman, PhD, Shannon A Gregory, Sharon K Thoma, PharmD, Shelley H Beausoleil, Sherri J Jackson, Shirley J Berryman, Shirshendu K Deb, PhD, Sidney B Priesmeyer, Simone E Pitts, Sneha S Patel, Stacey S Degarmo, Stephanie A Slater, MS, Stephen C Smith, Stephen D Brown, Stephen D Eich, Steven C Madzo, Steven D Kehoe, Steven E Bowen, PhD, Steven Fong, MS, PhD, Steven P Donald, Stuart W Russell, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Suyang Qin, Syed N Ali, Taichun Qin, PhD, Tara L Greene, Tara L King, Thai T Duong, Thao T Kwan, Thea C Grome, Thomas E Friel, Thomas J Arista, Thuy T Nguyen, LCDR, Thuy Y Nguyen, Tiara Nbrown Crosen, Timothy C Grome, Timothy J Schmidt, Timothy Wadkin, PhD, Tina M Pawlowski, Tina S Roecklein, Tonia F Bernard, Tonnie L Carter, Toyin B Oladimeji, Truong Xuan Nguyen (Andy), Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Veronica Fuentes, MS, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Virginia Carroll, PhD, Viviana Matta, Viviana R Ramirez, Vivin George, Walter L Fava, Walter N Lange, Wanda Y Honeyblue, Warren J Lopicka, Wayne E Seifert, Wendy G Tan, PhD, William D Tingley, William Hallett, PhD, William V Millar, Xianghong Jing (Emily), PhD, Xiaokuang Lai, PhD, Xiaoping Guan, Xiaoshi Wang, Xu Michael Di, PhD, Yangmin Ning, Yanming An, PhD, Yehualashet A Gessesse, Yetao Jin, PhD, Yi Wang, PhD, Ying Xin Fan, PhD, Yumi J Hiramine, Yun Wu, PhD, Yvins Dezan, Zachary L Stamm, Zerita White, Zhang Zhao, PhD, Zhenzhen Liu, PhD, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhong Zhao, PhD, Zhongren Wu, Ziyang Su, PhD, Zonglin Hu

Michael Shanks, MS's Documents

Publish Date Document Type Title
October, 2022 EIR Eli Lilly and Company - EIR, 2022-10-21
April, 2017 FDA 483 Biocon Biologics Limited - Form 483, 2017-04-07
November, 2018 EIR Pharmaceutics International, Inc. - EIR, 2018-11-09
February, 2021 EIR PYRAMID Laboratories, Inc. - EIR, 2021-02-03
August, 2022 EIR Intas Pharmaceuticals Limited - EIR, 2022-08-09
December, 2019 FDA 483 Response Ajinomoto Althea, Inc. - Form 483R, 2019-12-20
January, 2023 FDA 483 Ajinomoto Althea, Inc. - Form 483, 2023-01-16
February, 2021 FDA 483 PYRAMID Laboratories, Inc. - Form 483, 2021-02-03
September, 2020 EIR Catalent Indiana, LLC - EIR, 2020-09-02
December, 2019 EIR Ajinomoto Althea, Inc. - EIR, 2019-12-20
May, 2022 FDA 483 Patheon Biologics LLC - Form 483, 2022-05-02
October, 2022 FDA 483 Eli Lilly and Company - Form 483, 2022-10-21
February, 2021 FDA 483 Response PYRAMID Laboratories, Inc. - Form 483R, 2021-02-11
July, 2022 FDA 483 Hanmi Pharm. Co., Ltd. - Form 483, 2022-07-05
September, 2020 FDA 483 Response Catalent Indiana, LLC - Form 483R, 2020-09-23
August, 2017 FDA 483 Alexion Pharma International Operations Limited - Form 483, 2017-08-18
October, 2017 FDA 483 FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2017-10-31
March, 2018 EIR Sandoz GmbH - EIR, 2018-03-02
September, 2014 FDA 483 Sandoz GmbH - Form 483, 2014-09-16
February, 2019 FDA 483 Biocon Biologics Limited - Form 483, 2019-02-15
October, 2021 EIR Bristol-Myers Squibb Company - EIR, 2021-10-20
February, 2022 FDA 483 Lonza AG - Form 483, 2022-02-03
May, 2018 EIR Samsung Biologics Co., Ltd. - EIR, 2018-05-11
February, 2023 FDA 483 Genentech, Inc. - Form 483, 2023-02-02
July, 2021 FDA 483 Par Sterile Products LLC - Form 483, 2021-07-20
April, 2017 FDA 483 Biocon Limited - Form 483, 2017-04-03
July, 2018 FDA 483 Boehringer Ingelheim Pharma GmbH and Co. KG - Form 483, 2018-07-10
January, 2016 FDA 483 Amgen Manufacturing Ltd - Form 483, 2016-01-22
May, 2017 FDA 483 Yuhan Chemical Inc - Form 483, 2017-05-19
May, 2018 FDA 483 Samsung Biologics Co., Ltd. - Form 483, 2018-05-11
March, 2015 FDA 483 Lonza AG - Form 483, 2015-03-31
September, 2020 FDA 483 Catalent Indiana, LLC - Form 483, 2020-09-02
December, 2018 FDA 483 Aspen SA Sterile Operations (Pty) Ltd - Form 483, 2018-12-04
November, 2018 FDA 483 Pharmaceutics International, Inc. - Form 483, 2018-11-09
March, 2018 FDA 483 Lek d.d. - Form 483, 2018-03-02
December, 2019 FDA 483 Ajinomoto Althea, Inc. - Form 483, 2019-12-20
February, 2018 FDA 483 Sandoz GmbH - Form 483, 2018-02-20
July, 2015 FDA 483 Human Genome Sciences, Inc. - Form 483, 2015-07-24
May, 2021 FDA 483 AGC Biologics A/S - Form 483, 2021-05-10
November, 2022 FDA 483 MediWound Ltd - Form 483, 2022-11-15
July, 2019 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - Form 483, 2019-07-17
February, 2023 FDA 483 Genentech, Inc. - Form 483, 2023-02-02
August, 2022 FDA 483 Biocon Biologics Limited - Form 483, 2022-08-26
November, 2018 EIR Pharmaceutics International, Inc. - EIR, 2018-11-09
June, 2015 FDA 483 Eli Lilly Kinsale Limited - Form 483, 2015-06-26
August, 2022 FDA 483 Intas Pharmaceuticals Limited - Form 483, 2022-08-09
October, 2019 FDA 483 Astellas Pharma Inc. - Form 483, 2019-10-07
January, 2023 FDA 483 Tanvex BioPharma USA, Inc - Form 483, 2023-01-24
November, 2023 FDA 483 Patheon Biologics LLC - Form 483, 2023-11-10
January, 2024 FDA 483 Alvotech Hf - Form 483, 2024-01-19

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