FDA Investigator Kim Lthomas Cruse

Kim Lthomas Cruse has conducted inspections on 90 sites in 18 countries as of 27 Jun 2016. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
90
Last Inspection Date:
27 Jun 2016
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Denmark, Switzerland, Italy, China, Ireland, Japan, Finland, France, Hungary, Australia, Germany, United Kingdom of Great Britain and Northern Ireland, Spain, New Zealand, South Africa, India, Croatia
FDA Investigators that have inspected at least one site in common with Kim Lthomas Cruse:
Adam R Cooke, Ademola O Daramola, Adetutu M Gidado, Alan P Kurtzberg, Alexandra B Pitkin, Alexandria L Capuano, Alice S Tsao, Allison A Rodriguez, Almaris N Alonso, Althea A Williams, Amalia C Himaya, Amanda L Fyles, Amatul H Marium, Amber G Wardwell, Amir Alavi, Amy C Jordan, Anastasia G Lolas, Anastasia M Shields, Anderson, Andrei Perlloni, Andrew K Haack, PhD, Andrew Le, Andrew S Limson, Andy B Lee, Angela Shepas, Anh M Lac, Anita Narula, PhD, Anjali Shukla, PhD, Ann Marie Montemurro, Anna Lazar, Anthony A Charity, April C Inyard, April P Shaw, Arie C Menachem, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Arsen Karapetyan, Ashar P Parikh, Atul J Agrawal, Azza Talaat, Babajide Michael Osunsanmi, Barbara J Rincon, Barbara Jwilimczyk Macri, Barry Cherney, PhD, Bichsa T Tran, Bijoy Panicker, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brenda W Uratani, PhD, Brian J Ryan, Brian P Putz, Brien C Fox, Bruce H Mccullough, Bryan A Galvez, Calvin B Koerner, Calvin Foulks, Candace Y Gomez Broughton, Carl A Anderson, Carl A Huffman, III, Carl Lee, Carla J Lundi, Carolina D Vasquez, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Cathleen A Carr Sharpe, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Cecilia H Kieu, Charisse K Green, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Chelsea N Sealey, Cheron M Portee, Cheryl A Clausen, Christina C Santos, Christina V Santos, Christopher D Leach, Christopher J Freebairn, Christopher R Czajka, Christopher T Middendorf, Claire M Minden, Claudia Mperez Kasmarski, Comyar Shoghi, Crystal Monroy, Cynthia J Lee, MS, Cynthia J Tsui, Cynthia Jim, CSO, Cynthia M Goudeau, Daniel J Roberts, Daniel L Zheng, Daniel W Cline, Darla J Christopher, Darren S Brown, David G Eng, David M Beltran, David R Delucia, David Serrano, Davinna Ligons, PhD, Dawn E Barkans, Deborah A Greco, Debra I Love, Dejon N Harris, Demitria J Xiradakis, Dennis Cantellops Paite, Deyaa Shaheen, Diana M Rand, Diane Cvan Leeuwen, Diane L Raccasi, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Don H Bark, PhD, Dongping Dai, PhD, Donna Ltartaglino Besone, Donna Mwilliams Hill, PhD, Douglas C Kovacs, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Jason R Caballero, Dr. Mark J Seaton, PhD, Dr. Robert C Horan, MD, Dustin R Abaonza, Dyana K Stone, Edmund F Mrak, Jr, Eileen A Liu, Elaine A Bunch, Elizabeth Ad Girard, Elizabeth Juarez, Elizabeth Ll Edwards, Ellen C Weisensel, Emest F Bizjak, Eric L Dong, BS, Eric M Mueller, PharmD, Erika V Butler, Esther B Gamallo Herrera, Esther C Broner, PhD, Evelyn Wong, Farhana Khan, Felix Maldonado, Frances Namuswe, PhD, Freddy Ortiz Colon, Frederick L Fricke, Gam S Zamil, Gary J Lehr, Gavin T Cua, Gene D Arcy, George J Flynn, Gerald B Seaborn, Jr, Geraldine D Sanders, Gerardo Z Vazquez, Gilbert T Salud, Greg K Keshishyan, Gregory A Berg, Gwyn G Dickinson, Haley H Seymour, Haroon Vohra (NMI), Hasan A Irier, PhD, Hector A Carrero, Heidy C Perales, Helen B Ricalde, Heriberto Negron Rivera, Himanshu Gupta, PhD, Homero W Aguilar, Hossein Khorshidi, PhD, Hung H Do, MS, Iram R Hassan, PhD, Iris C Macinnes, Ivis L Negron, James A Barreto, James A Lane, James A Liubicich, James B Arnett, James C Maclaughlin, James I Giefer, James M Timper Jr, James P Stumpff, James R Fleckenstein, Jamie M Du, Jane S Wernberg, Janet D Blount, Jawaid Hamid, Jee Chung, PhD, Jeffery A Johnson, Jeffrey D Meng, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer D Hollstrom, Jennifer Gogley, Jennifer L Degroot, Jennifer L Huntington, Jennifer L Johnson, Jennifer M Gogley, Jeremy Beber, Jeremy H Nguyen, Jessica Chery, Jinnie Kokiatkulkij, Joan T Briones, Jocelyn E Massey, Jocelyn E Sparks, Joe X Phillips, Joel D Hustedt, Joel Welch, PhD, Joey V Quitania, John A Gonzalez, John L Stevens, John R Myung, Jolanna A Norton, Jonathan G Matrisciano, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, Jose M Cayuela, Jose Ohernandez Guzman, Joseph X Phillips, Juan J Casado, Juanita Banuelos, Judy C Nepsa, Julia Ventura, Julie A Rorberg, Julie A Stocklin, Julie D Bringger, Junho Pak, Justin A Boyd, Justine M Corson, Justine Tomasso, Ka L Wong, Kalavati Suvarna, PhD, Karen A Wolnik, Karen E D'orazio, Karen L Kosar, Karen Takahashi, Kari M Johansen, Karishma G Gopaul, Katherine E Jacobitz, Katherine Szestypalow, Kathleen R Jones, PhD, Kathy Chiu, Kathy Kuo, Keith P Iams, Kelley, Kellia N Hicks, Kelly I Anderson, Kelvin Cheung, Kelvin X Sanders, Kendra A Biddick, Kenneth H Williams, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kirtida Patel, Kristin M Abaonza, Kristy A Zielny, Kula N Jha, Lakecha N Lewis, Lance Mde Souza, MBA, Lanita F Kelley, Larry K Austin, Laura Fontan, MS, Laurel A Beer, Laurenee L Adeoshun, Laurie B Frazier, Lawrence J Stringer, Lawrence W Farina, LCDR Debra Emerson, LCDR Jennifer H Rhyu, LCDR Michael H Tollon, Leanna M Slarsky, Leonard H Lavi, Liatte Kreuger, PharmD, Lillian S Wu, Lilly O Barton, Liming Zhang, Linda F Murphy, Linda Linh N Adams, Linda M Cheny, Linda Thai, Ling Yu L Liu, Loretta J Jordan, Lori M Newman, Lorie S Hannappel, Louis B Cencetti, LT Richard A Lyght, Lucas B Leake, Lucila B Nwatu, Luella J Rossi, Luis P Torres, Mai X Huynh, Marcia B Williams, Marco S Esteves, Marcus F Yambot, Margaret A Smithers, Margaret M Annes, Margaret M Sands, Marianela Aponte Cruz, Marie F Morin, Marie Falcone, Marie K Kinkade, Marie T Falcone, Marijo B Kambere, PhD, Mariza M Jafary, Mark C Saale, Mark R Mcclain, Mark W Babbitt, Mary E Farbman, PhD, Mary E Storch, Mary Jeanet Mcgarry, Matthew B Casale, Matthew J Johnson, Matthew R Dionne, Maurice M Sheehan, Maxwell Van Tassell, PhD, Maxyne T Lam, Mei Chiung Huang (Jo), Melanie M Walker, Michael D Garcia, Michael P Sheehan, Michael R Goga, Michael S Araneta, Michael Shanks, MS, Michael T Cyrus, Michele Gottshall, Michele L Forster, PhD, Michele L Obert, Michele Perry Williams, Michelle A Marsh, Michelle J Hines, Miguel A Martinez Perez, Mihaly S Ligmond, Mindy M Chou, Minh D Phan, Mohsen Rajabi Abhari, FDA, Monika Borkowska, Mra B Kamberem, Mra Davism, Mra Greenc, Mra Mcculloughj, Nabeela J Chaudhry, Nancy G Schmidt, Nancy L Rolli, Nayan J Patel, Neal L Adams, Neil J Bonzagni, PhD MPH, Nelly N Tran, Nicholas L Hunt, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Nicole E Knowlton, Noreen Muñiz, Nutan Mytle, Omotunde O Osunsanmi, Pal S Mayasandra, Pankaj H Amin, Paquita F Segarra, Paraluman S Leonin, Parul M Patel, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paul Mouris, Paul R Whitby, Peter Abel, Peter C Chow, Peter Caparelli, Peter E Baker, Peter R Caparelli, Peter R Lenahan, Peter S Diak, Philip F Istafanos, DMV, MS, Phillip L Toy, Prabhu P Raju, Prasad Peri, PhD, Rachael A Moliver, Rachel C Harrington, Rachel C Stanton, Raihan A Chowdhury, Ramesh Potla, PhD, Randy L Self, Raymond T Oji, Rebecca Rodriguez, Regina T Brown, Renee S Blosser, Richard E Needham, Richard H Penta, Richard Jay Tucker, RS, Richmond K Yip, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert Darius, Robert J Martin, Robert M Tillman, Rochelle K Kimmel, Roger F Zabinski, Rona Leblanc, PhD, Ronald L Koller, Ronda Leblanc, Roy R Rinc, Rumany C Penn, PharmD, Russell J Glapion, Russell K Riley, Ryan J Borges, Saied A Asbagh, Saleem A Akhtar, Sandra A Boyd, Sandra A Hughes, Sandra L Shire, DMD, MPA, Sandra S Saniga, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sarah A Hassas, Sarah Arden, Scott N Lim, Scott R Nichols, PhD, Sean P Desbrow, Sean R Marcsisin, Selene T Torres, Seneca D Toms, Shannon B Ruelle, Sharon K Thoma, PharmD, Shawn R Gould, Shirley J Berryman, Shirnette D Ferguson, Sidney B Priesmeyer, Sidonie J Takougang, Simone E Pitts, Sonia R Peterson, Sony Mathews, Sonya L Karsik, RAC, Sparky L Bartee, Srinivas R Chennamaneni, PhD, Stanley Au, Stephanie A Slater, MS, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Steven C Madzo, Steven D Kehoe, Steven E Porter, Jr, Steven Fong, MS, PhD, Steven M Weinman, Sue Lee Chan, Sundy V Sedwick, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan T Hadman, Susanna E Ford, Taichun Qin, PhD, Tajah L Blackburn, Tamala P Bogan, Tamala P Magee, Tamika White, Temar Q Williams, Teresa I Navas, Teresa T Cain, Terrance L Thomas, Terri L Dodds, Thanh M Andrews, Thao T Kwan, Thao X Tran, Theresa Kirkham (NMI), Thomas A Peter, Thomas E Friel, Thomas J Arista, Thomas R Beilke, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Timothy T Kapsala, Tony J Wu, Torrance J Slayton, Toyin B Oladimeji, Tracey T Duong, Travis S Bradley, Truong Xuan Nguyen (Andy), Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valerie L Whipp, Vashti E Bocker, Vickie L Anderson, Victoria A Wagoner, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Viviana Matta, Vlada Matusovsky, Walden H Lee, Wayne E Seifert, Wenzheng Wendy Zhang, William J Leonard, William V Millar, Xiaohui Shen, Xiaokuang Lai, PhD, Yanming An, PhD, Yasamin Ameri, Yong Hu, Yumi J Hiramine, Yvette Mlacour Davis, Yvonne C Wilkes, Yvonne Y Wu, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zhong Li, PhD, Zi Qiang Gu

Kim Lthomas Cruse's Documents

Publish Date Document Type Title
May, 2002 EIR Amphastar Pharmaceuticals, Inc. - EIR, 2002-05-02
December, 2014 EIR IDT Biologika GmbH - EIR, 2015-01-21
October, 2013 EIR ASEGUA THERAPEUTICS LLC - EIR, 2013-10-09
December, 2013 FDA 483 Bioduro LLC - Form 483, 2013-12-20
October, 2002 EIR Amphastar Pharmaceuticals, Inc. - EIR, 2002-10-09
February, 2003 EIR Olon SpA - EIR, 2003-02-13
February, 2003 FDA 483 Response Alphalytik Pharmaservice GmbH - Form 483R, 2003-02-24
July, 2011 FDA 483 Labor LS SE & Co. KG - Form 483, 2011-07-21
February, 2003 FDA 483 Alphalytik Pharmaservice GmbH - Form 483, 2003-02-07
December, 2013 EIR Bioduro LLC - EIR, 2013-12-20
August, 2002 EIR Xellia Pharmaceuticals Ltd. - EIR, 2002-09-13
April, 2006 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2006-04-03
August, 2002 FDA 483 Response Pliva Hrvatska d.o.o. - Form 483R, 2002-10-28
November, 2004 FDA 483 Orgapharm - Form 483, 2004-11-11
December, 2014 FDA 483 IDT Biologika GmbH - Form 483, 2014-12-09
November, 2002 FDA 483 Polypeptide Laboratories, Inc. - Form 483, 2002-11-27
August, 2002 EIR Pliva Hrvatska d.o.o. - EIR, 2002-09-13
December, 2003 FDA 483 Amgen, Inc - Form 483, 2003-12-12
June, 2000 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2000-06-29
July, 2006 FDA 483 GRAM Laboratories, Inc. - Form 483, 2006-07-07
April, 2006 FDA 483 Daito Pharmaceutical Co., Ltd - Form 483, 2006-04-20
April, 2013 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2013-04-26
April, 2009 EIR Bespak Europe Ltd - EIR, 2009-04-03
August, 2013 EIR Alliance Medical Products, Inc. (dba Siegfried Irvine) - EIR, 2013-08-16
August, 2002 FDA 483 Response Xellia Pharmaceuticals Ltd. - Form 483R, 2002-09-13
September, 2003 FDA 483 Med-Pharmex, Inc - Form 483, 2003-09-12
May, 2010 FDA 483 HELSINN BIREX PHARMACEUTICALS LIMITED - Form 483, 2010-05-27
November, 2012 FDA 483 Watson Laboratories, Inc. - Form 483, 2012-11-26
November, 2004 EIR Orgapharm - EIR, 2004-12-14
February, 2013 FDA 483 Impax Laboratories, LLC. - Form 483, 2013-02-28
August, 2002 FDA 483 Xellia Pharmaceuticals Ltd. - Form 483, 2002-08-24
May, 2010 EIR Teva Parenteral Medicines, Inc. - EIR, 2010-05-14
July, 2003 FDA 483 GRAM Laboratories, Inc. - Form 483, 2003-07-31
December, 2003 FDA 483 Response Amgen, Inc - Form 483R, 2004-01-06
June, 2009 FDA 483 Element Materials Technology Pharma US LLC - Form 483, 2009-06-15
February, 2003 FDA 483 Response Olon SpA - Form 483R, 2003-03-21
July, 2009 FDA 483 Truett Laboratories, Inc. - Form 483, 2009-07-10
March, 2002 FDA 483 Med-Pharmex, Inc - Form 483, 2002-03-20
August, 2002 FDA 483 Pliva Hrvatska d.o.o. - Form 483, 2002-08-30
June, 2012 FDA 483 Novartis Pharma Stein AG - Form 483, 2012-06-22
October, 2002 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2002-10-09
August, 2013 FDA 483 Alliance Medical Products, Inc. (dba Siegfried Irvine) - Form 483, 2013-08-16
December, 2003 EIR Amgen, Inc - EIR, 2003-12-12
October, 2013 FDA 483 Response ASEGUA THERAPEUTICS LLC - Form 483R, 2013-10-31
October, 2013 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2013-10-09
June, 2003 EIR Kindeva Drug Delivery L.P. - EIR, 2003-06-06
April, 2014 FDA 483 Watson Laboratories, Inc. - Form 483, 2014-04-21
June, 2003 FDA 483 Kindeva Drug Delivery L.P. - Form 483, 2003-06-06
July, 2015 FDA 483 Pharmasol Corporation - Form 483, 2015-07-16
May, 2002 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2002-05-02
May, 2004 FDA 483 Watson Laboratories, Inc. - Form 483, 2004-05-06
January, 2011 FDA 483 Expert Chemical Analysis, Inc. - Form 483, 2011-01-28
January, 2007 EIR Bioduro LLC - EIR, 2007-01-22
June, 2002 EIR Irvine Pharmaceutical Services, Inc. - EIR, 2002-06-13
May, 2010 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2010-05-07
June, 2011 FDA 483 Bachem Americas, Inc. - Form 483, 2011-06-02
February, 2008 EIR Genentech, Inc. - EIR, 2008-11-25
June, 2000 EIR Fougera Pharmaceuticals Inc. - EIR, 2000-06-29
February, 2003 EIR Alphalytik Pharmaservice GmbH - EIR, 2003-03-03
March, 2003 FDA 483 B. Braun Medical Inc. - Form 483, 2003-03-26
February, 2003 FDA 483 Olon SpA - Form 483, 2003-02-13
June, 2000 FDA 483 Response Fougera Pharmaceuticals Inc. - Form 483R, 2000-07-24
October, 2004 FDA 483 Gilead Sciences, Inc. - Form 483, 2004-10-08
March, 2006 FDA 483 Chemica - Form 483, 2006-03-06

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