FDA Investigator Michael Shanks, MS

Michael Shanks, MS has conducted inspections on 68 sites in 19 countries as of 17 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
68
Last Inspection Date:
17 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Korea (Republic of), United States of America, Slovenia, India, Puerto Rico, Netherlands, Poland, Italy, South Africa, Germany, Ireland, Austria, Japan, China, Switzerland, Australia, Iceland, Israel, Denmark
FDA Investigators that have inspected at least one site in common with Michael Shanks, MS:
Adaliz Santaliz Cruz, Adam R Cooke, Aditi S Thakur, Alan A Rivera, Alan L Truong, Alanna L Mussawwir 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 L Deyampert, 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, Ayyappan Rathakrishnan, Azza Talaat, Babajide Michael Osunsanmi, Barbara A Gullick, Barbara J Wilcox, PhD, Barbara Janine Breithaupt, Bei Y He, Benjamin J Smith, Bijoy Panicker, Bingchen Du, PhD, 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, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Candace Y Gomez Broughton, Carl A Huffman, III, Carl Lee, Carla J Lundi, Carole L Jones, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Cathleen A Carr Sharpe, CDR Donald Ertel, Chaltu Nwakijra, Charanjeet Jassal, Charles I Ann, Charles L Zhou, Charles M Edwards, Charles Yuanchia Kuo, PhD, Chen Sun, PhD, Cheryl A Clausen, Chiang Syin, PhD, Chikako Torigoe, PhD, Christian D Lynch (CDL), Christina K Theodorou, Christopher D Leach, Christopher Downey, PhD, Christopher R Czajka, Claudia Mperez Kasmarski, Colleen Thomas, PhD, Concepcion Cruz, Jr, Constantin Y Philopoulos, Corrine M Carter, Cristina Ausin Moreno, PhD, Cynthia Jim, CSO, Cyrus Agarabi, PhD, 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 H 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, Dr. Zhihao Qiu (Peter), PhD, 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, Erika V Butler, Erin D Mccaffery, Esther C Broner, PhD, Evelyn Wong, Ewa Marszal, PhD, Felix Maldonado, Frances Namuswe, PhD, Francis A Guidry, Gene D Arcy, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Gerald Feldman, Gerald M Feldman, PhD, Grace Deneke, Graeme E Price, Graeme Price, Gwyn G Dickinson, Hamet M Toure, PharmD MPH, Hector Jcolon Torres, Helen B Ricalde, Henry K Lau, Herbert M Corbello, Hyung Yul Lee, Ian L Mcwilliams, Ibad U Khan, Ivis L Negron, 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, 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, Jill J Tillman, Jing Fang, Joan T Briones, Joel D Martinez, Joey V Quitania, John A Gonzalez, John D White, Jolanna A Norton, Jon P Antoniou, Jonah S Ufferfilge, Jonathan W Chapman, Joohi Castelvetere, Jorge L Guadalupe, Jorge L Lajara, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose M Gonzalez, 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, Kamal N Tiwari, 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 Kuo, Kathy Lee, Kelley, Kelvin Cheung, 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 Mde 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, Lauren N Howard, Laurie Graham, Laurie Nelson, Laurie P Norwood, Laurimer Kuilan Torres, Lauryl A Smith, Lawrence Harmon, Jr, Lawrence J Stringer, LCDR Jennifer H Rhyu, LCDR Sean Byrd, Lei Zhang, PhD, Leigh Anne Myers, Leiyun Boone, PhD, Lesley K Satterwhite, Leslie Arivera Rosado, PhD, Lestine C Webb, Libia M Lugo, Lillie D Witcher, Linda F Murphy, Linda Thai, Lindsey Brown, PhD, Lindsey S Fleischman, Linh Tu, Liqun Zhao, Lisa L Flores, Lisa M Bellows, Logan T Williams, Lori S Lawless, Lorie S Hannappel, LT Daveta L Bailey, 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 Gutierrez Hoffman, PhD, Maria Gutierrez Lugo, PhD, 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 Lrodriguez 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 Glendenning, Michele L Obert, Michele Perry Williams, Michelle Rfrazier Jessen, PhD, Michelle Yclark Stuart, Miguel A Martinez Perez, Mihaly S Ligmond, Milos Dokmanovic, PhD, Milva E Melendez Perales, Min Shanmabel Liu, Mindy M Chou, Mizanne E Lewis, Monica Commerford, PhD, Monica E Murie, Monica Markovski, PhD, Monika Borkowska, Montgomery Montgomery, Karen M, Mra B Kamberem, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Mra V Millarw, Muna Algharibeh, Muralidhara B Gavini, PhD, Myra K Casey, Myriam M Sosa, Nadeem I Chaudhry, Nailing Zhang, Nayan J Patel, Neal L Adams, Neali H Lucas, Nealie C Newberger, Nebil A Oumer, Nicholas A Violand, Nicholas L Hunt, Nicholas L Paulin, Nicholas Obiri, PhD, Nikolay Spiridonov, Nirjal Bhattarai, Noreen Muñiz, Nydia E Colon, Olumide A Martins, Omotunde O Osunsanmi, Parul M Patel, Patricia A Cochran, Patricia F Hughes, PhD, 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, Rachel C Harrington, Rachel Novak, PhD, 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 Jennings, Robert M Barbosa, Robert Rodriguez, Rodney D Combs, Rodney G Raiford, Rosanna M Goodrich, Rose 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 C Lute, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sean P Desbrow, Sean R Marcsisin, Seneca D Toms, Serge L Beaucage, Shadia Zaman, PhD, Shannon A Gregory, Sharon K Thoma, PharmD, Sheilyn H Huang, 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, Susan T Hadman, Susanne M Richardson, MS RAC, Suyang Qin, Syed N Ali, Taichun Qin, PhD, Tara L Greene, Tara L King, Teegan Dellibovi Ragheb, PhD, Thai T Duong, Thao T Kwan, Thea C Grome, Thomas E Friel, Thomas J Arista, Thuy T Nguyen, LCDR, 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, Walden H Lee, 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 N Wang, Xu Michael Di, PhD, Yangmin Ning, Yanming An, PhD, Yasamin Ameri, Yehualashet A Gessesse, Yetao Jin, PhD, Yi Wang, PhD, Ying Xin Fan, PhD, Yongmin Liu, Yuan Chia Kuo, Yumi J Hiramine, Yun Wu, PhD, Yvins Dezan, Zachary L Stamm, Zerita White, Zhang Zhao, PhD, Zhenzhen Liu, PhD, Zhong Li, PhD, Zhong Zhao, PhD, Zhongren Wu, Ziyang Su, PhD, Zonglin Hu

Michael Shanks, MS's Documents

Publish Date Document Type Title
December, 2019 FDA 483 Ajinomoto Althea, Inc. - Form 483, 2019-12-20
May, 2018 FDA 483 Samsung Biologics Co., Ltd. - Form 483, 2018-05-11
November, 2018 EIR Pharmaceutics International, Inc. - EIR, 2018-11-09
January, 2023 FDA 483 Tanvex BioPharma USA, Inc - Form 483, 2023-01-24
October, 2022 FDA 483 Eli Lilly and Company - Form 483, 2022-10-21
January, 2023 FDA 483 Ajinomoto Althea, Inc. - Form 483, 2023-01-16
July, 2019 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - Form 483, 2019-07-17
July, 2015 FDA 483 Human Genome Sciences, Inc. - Form 483, 2015-07-24
July, 2021 FDA 483 ENDO USA, Inc. - Form 483, 2021-07-20
September, 2014 FDA 483 Sandoz GmbH - Form 483, 2014-09-16
February, 2023 FDA 483 Genentech, Inc. - Form 483, 2023-02-02
July, 2018 FDA 483 Boehringer Ingelheim Pharma GmbH and Co. KG - Form 483, 2018-07-10
January, 2016 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2016-01-22
May, 2022 FDA 483 Patheon Biologics LLC - Form 483, 2022-05-02
August, 2022 FDA 483 Intas Pharmaceuticals Limited - Form 483, 2022-08-09
February, 2022 FDA 483 Lonza AG - Form 483, 2022-02-03
February, 2019 FDA 483 Biocon Biologics Limited - Form 483, 2019-02-15
February, 2021 FDA 483 PYRAMID Laboratories, Inc. - Form 483, 2021-02-03
December, 2019 FDA 483 Response Ajinomoto Althea, Inc. - Form 483R, 2019-12-20
September, 2020 EIR Catalent Indiana, LLC - EIR, 2020-09-02
December, 2019 EIR Ajinomoto Althea, Inc. - EIR, 2019-12-20
November, 2018 EIR Pharmaceutics International, Inc. - EIR, 2018-11-09
April, 2017 FDA 483 BIOCON LIMITED - Form 483, 2017-04-03
February, 2021 FDA 483 Response PYRAMID Laboratories, Inc. - Form 483R, 2021-02-11
March, 2018 EIR Sandoz GmbH - EIR, 2018-03-02
February, 2018 FDA 483 Sandoz GmbH - Form 483, 2018-02-20
August, 2017 FDA 483 Alexion Pharma International Operations Limited - Form 483, 2017-08-18
March, 2018 FDA 483 Lek d.d. - Form 483, 2018-03-02
October, 2022 EIR Eli Lilly and Company - EIR, 2022-10-21
September, 2020 FDA 483 Response Catalent Indiana, LLC - Form 483R, 2020-09-23
July, 2022 FDA 483 Hanmi Pharm. Co., Ltd. - Form 483, 2022-07-05
October, 2017 FDA 483 FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2017-10-31
October, 2021 EIR Bristol-Myers Squibb Company - EIR, 2021-10-20
November, 2018 FDA 483 Pharmaceutics International, Inc. - Form 483, 2018-11-09
September, 2020 FDA 483 Catalent Indiana, LLC - Form 483, 2020-09-02
March, 2015 FDA 483 Lonza AG - Form 483, 2015-03-31
November, 2023 FDA 483 Patheon Biologics LLC - Form 483, 2023-11-10
April, 2017 FDA 483 Biocon Biologics Limited - Form 483, 2017-04-07
May, 2018 EIR Samsung Biologics Co., Ltd. - EIR, 2018-05-11
October, 2019 FDA 483 Astellas Pharma Inc. - Form 483, 2019-10-07
June, 2015 FDA 483 Eli Lilly Kinsale Limited - Form 483, 2015-06-26
November, 2022 FDA 483 MediWound Ltd - Form 483, 2022-11-15
August, 2022 FDA 483 Biocon Biologics Limited - Form 483, 2022-08-26
May, 2017 FDA 483 Yuhan Chemical Inc - Form 483, 2017-05-19
December, 2018 FDA 483 Aspen SA Sterile Operations (Pty) Ltd - Form 483, 2018-12-04
February, 2021 EIR PYRAMID Laboratories, Inc. - EIR, 2021-02-03
January, 2024 FDA 483 Alvotech Hf - Form 483, 2024-01-19
August, 2022 EIR Intas Pharmaceuticals Limited - EIR, 2022-08-09
May, 2021 FDA 483 AGC Biologics A/S - Form 483, 2021-05-10
May, 2024 FDA 483 MSD Ireland (Carlow) - Form 483, 2024-05-28
July, 2024 FDA 483 Lonza Biologics, Inc. - Form 483, 2024-07-12
July, 2023 FDA 483 Roche Diagnostics GmbH - Form 483, 2023-07-14
August, 2023 FDA 483 Shanghai Henlius Biologics Co.,Ltd - Form 483, 2023-08-04
June, 2024 FDA 483 KBI Biopharma, Inc. - Form 483, 2024-06-18
February, 2024 FDA 483 BSP Pharmaceuticals SpA - Form 483, 2024-02-29
November, 2021 FDA 483 GlaxoSmithKline Manufacturing SpA - Form 483, 2021-11-12

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