FDA Investigator James R Fleckenstein

James R Fleckenstein has inspections in 27 countries as of 13 Oct 2023. James R Fleckenstein has collaborated with a combinined 6838 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
380
Last Inspection Date:
13 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Canada, Czechia, China, India, Latvia, Russian Federation, Belgium, Bulgaria, Italy, Ukraine, Poland, Turkey, Denmark, Romania, Netherlands, United Kingdom of Great Britain and Northern Ireland, Australia, France, Germany, Singapore, Norway, Argentina, South Africa, Mexico, Japan
Co-Investigator(s):
A Williams, Abdur Razzaque, Adaliz Santaliz Cruz, Ademola O Daramola, Alan L Truong, Alan M Stevens, Albert Rodriguez, Alexandria L Capuano, Alford R Taylor, Allen F Hall, Althea A Williams, Amalia C Himaya, Amalia Himaya, Amanda E Lewin, PhD, Amanda L Fyles, Amir Alavi, Anastasia M Shields, Anderson, Andrea A Branche, Andrew K Haack, PhD, Andrew Saunders, Angela Shepas, Angelica G Aziz, Anita Narula, PhD, Arie C Menachem, Arsen Karapetyan, Ashar P Parikh, Ashley D Abraham, Avery J Dennis, Barbara A Rusin, Barbara M Frazier, Barbara M Frezior, Barry Cherney, PhD, Bharat Khurana, Bichsa T Nguyen, Bichsa T Tran, Billi Jom Johnson, Binh T Nguyen, Bo Chi, PhD, Bonnie E Conley, Bonnie E Pierson, Bonnie I Needleman, Brenda L Reihing, Brian J Ryan, Brian P Putz, Brien C Fox, Bryan A Galvez, Bryce E Mansfield, Cara M Minelli, Carla J Lundi, Carr Sharpe, Carrie A Hughes, Caryn M Mcnab, Catherine J Laufmann, CDR Sean T Creighton, Celena Ngo, Charles L Larson, Chelsea N Sealey, Cheron M Portee, Cheryl D Mccall, Cheryl G Scott, Christina D Mello, Christina V Santos, Christine I Shaw, Christopher D Rush, Christopher D Washington, Christopher R Czajka, Christopher S Genther, Colleen E Burke, Comyar Shoghi, Courtney N Long, Creighton T Tuzon, Cynthia A Harris, MD, RN, Cynthia L Gorveatt, Daniel W Cline, Dannie E Rowland, Darren S Brown, Darrin E Davis, David G Whitman, David Kalins, David Serrano, Davinna Ligons, PhD, Dawn C Olenjack, Deborah A Greco, Deborah A Nebenzahl, Dejon N Harris, Dennis G Kawabata, Desiree C Iya, Diane Cvan Leeuwen, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Donna Ltartaglino Besone, Donna Mwilliams Hill, Douglas W Atkins, Dr. Chunchang Fang, Dr. Sriram Subramaniam, PhD, Durell L Giles, Ebony D Sanon, Eileen A Liu, Eileen T Dupont, Elaine A Bunch, Elizabeth A Dakan, Elizabeth A Girard, Elizabeth Ad Girard, Elizabeth P Kinsella, Eric M Mueller, PharmD, Eric M Padgett, Erik M Slama, Evelyn Taha, Evelyn Wong, Finn A Slizza, Frances Namuswe, PhD, Francis J Eng, Gene D Arcy, Geoffrey K Kilili, Gerard Pde Leon, Graham N Giesen, Greg K Keshishyan, Gulshan R Anand, Haley H Seymour, Haley Seymour, Haroon Vohra (NMI), Harperd, Hasan A Irier, PhD, Herminio C Francisco, Himanshu Gupta, PhD, Hossein Khorshidi, PhD, Humberto Z Gomez, Hung H Do, MS, Hyojong Kwon, PhD, Ian A Pilcher, Iram R Hassan, PhD, Iris C Macinnes, Ivar J Sohn, James A Beaulieu, James A Lane, James B Arnett, James D Planchon, James E Bentson, James H Tanner, James K Kane, PhD, James P Stallings, James R Flockenstein, James R Heckenstein, James R Montero, Jamie M Du, Janet Janet, Janet Pulver, Janete F Guardia, Jasmine Y Wang, Javelle P Spann, Javier O Vega, Jee Chung, PhD, Jeffrey P Raimondi, Jennifer Alongie Vollom, Jennifer Gogley, Jennifer M Gogley, Jessica E Paulsen, Jessica L Johnson, Jinnie Kokiatkulkij, Joan A Loreng, Joan A Loreno, Joann F Fujikawa, Jocelyn E Massey, Jocelyn E Sparks, Jocelyn M Muggli, Joel D Hustedt, Joel Welch, PhD, Joey V Quitania, John A Gonzales, John A Gonzalez, John A Kadavil, PhD, John Dan, John L Stevens, John R Myung, Jolanna A Norton, Joseph M Edwin, Juanita Banuelos, Juanj N Wu, Juanj Wu, Judy C Nepsa, Jun Park, PhD, Ka L Wong, Karen A Coleman, Karen Emasley Joseph, Karen L Bauer, Karen M Cooper, Katherine E Jacobitz, Kathleen R Jones, PhD, Keith P Iams, Kelley, Kelvin Cheung, Kelvin X Sanders, Kendra A Biddick, Kenneth O Gee, PhD, Kenya Destin, Kerri E Butler, Kevin N Tran, Kham Phommachanh, Khin Mang U, MD, Kim Lthomas Cruse, Kimberly A Benson, Kimberly Lewandowski Walker, Kimberly M Lichter, Kip J Hanks, Kirtida Patel, Lakecha Lewis, Lakecha N Lewis, Langer, Lanita F Kelley, Laura Fontan, MS, Leonard H Lavi, Lewis K Antwi, Li Hongpaul Yeh, PhD, Lilly O Barton, Liming Zhang, Linda L Ng, Linda R Kuchenthal, Linda Thai, Ling Yul Liu, Lisa A Warner, Lori A Gioia, Lori J Silverstein, M Patriciaurphy Murphy, Mageet, Marcia Britt Williams, Marco A Solorio, Marcus F Yambot, Mariza M Jafary, Mark C Saale, Mark W Babbitt, Marlo Ianm Alintanahin, Marquis S Allen, Mary A Millner, Matthew C Watson, Matthew J Gretkierewicz, Matthew M Vernon, Maxyne T Lam, Mei Chen Mu, Melissa A Torres, Melkamu Getie Kebtie, PhD, Miaja Umaedi, Michael D Garcia, Michael D Kawalek, Michael F Schuette, Michael J Nerz, Michael O Stokke, Michael S Araneta, Michael Serrano, Michael T Cyrus, Michelle A Marsh, Miguel A Martinez, Mihaly S Ligmond, Minh D Phan, Mohsen Rajabi Abhari, FDA, Msdap Gonzlezk, Nabeela J Chaudhry, Natalie J Ayoub, Nelly N Tran, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Nicole M Gillette, Norman Wong, Omotunde O Osunsanmi, Pamela L Vega, Paquita F Segarra, Paul M Kawamoto, Paul R Whitby, Pauline N Logan, Pawan K Jain, Peter S Diak, Philip F Istafanos, DMV, MS, Phillip D Waldron, Phillip M Pontikos, Prabhu P Raju, Ralph Jerndal, Raymond W Brullo, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Richard L Rutherford, Richard W Tubb, Richmond K Yip, Robert C Coleman, Robert D Tollefsen, Robert Darius, Rocio Guzman Velazquez, Rodney T Allnutt, Roger F Zabinski, Ronald C Alexander, Ronald L Koller, Ronda Lebland, Ronda R Loyd Jones, Rosanna M Goodrich, Roy Baby, Ruben C Ayala, PharmD, Ruben G Abrajano, Sabrina J Dethloff, Samson O Oluseye, Sandra L Shire, DMD, MPA, Sandra R Kircus, Sara Jdent Acosta, Sarah A Hassas, Sarah Arden, Satheesh Thomas, Scott B Laufenberg, Scott K Zika, Scott R Nichols, PhD, Sean P Desbrow, Seema S Singh, Selene T Torres, Shafiq S Ahadi, Shannon B Ruelle, Shannon C Lane, Shaquenta Y Perkins, Sharon I Gundersen, Sherri N Rohlf, MD, Sidney B Priesmeyer, Sidonie J Takougang, Simone E Pitts, Sonia R Peterson, Sonya L Karsik, Srinivas R Chennamaneni, PhD, Srlram Subramaniam, PhD, Stanley Au, Stanley B Eugene, BS, BME, State Agency, Stephen R Souza, Steven E Porter, Jr, Steven Fong, MS, PhD, Sue Lee Chan, Sundy Ven, Sunitha K Rajaram, PhD, Susan F Laska, MS, Susan K Bain, Susan M Atcher, Susan M Jackson, Susan M Matthias, Susanna N Choi, Susant Hadman, Suzie L Kent, Taichun Qin, PhD, Tamala P Bogan, Tamala P Magee, Tania Y Hall, Tawny L Colling, Teena H Aiken, Teresa T Cain, Terrance L Thomas, Terri E Gibson, Terri L Dodds, Thai T Duong, Thao T Kwan, Thao Tran, Thao X Tran, That T Kwan, Thea C Grome, Theresa Kirkham (NMI), Thomas R Beilke, Tiki J Dixon, Tonia L Sawyer, Tracey T Duong, Traci C Kelm, Troy D Mansell, Trudy Papson, Trudy R Papson, Truong Xuan Nguyen (Andy), Trushani T Desai, Uttaniti Limchumroon (Tom), Vanessa R Muller, Vasant G Malshet, PhD, Vashti E Bocker, Vickie L Anderson, Victor H Loo, Vien Q Le, Virgilio F Pacio, CSO, Walden H Lee, Wanda B Coats, Wendy R Blame, William Regnault, PhD, William S Vitale, Wr Bowman, Xiaohui Shen, Xiaojun Yan, Yasamin Ameri, Yehualashet A Gessesse, Yumi J Hiramine, Yvette E Guillermo, Yvette Mlacour Davis, Yvonne C Wilkes, Yvonne T Lacour, Yvonne Y Wu

James R Fleckenstein's Documents

Publish Date Document Type Title
March, 2013 EIR TrueVision Systems Inc - EIR, 2013-03-12
September, 2004 EIR Advanced Bionics, LLC - EIR, 2004-09-15
December, 2015 FDA 483 Cedars-Sinai Medical Center - Form 483, 2015-12-07
August, 2014 EIR Integra Biotechnical LLC - EIR, 2014-08-27
December, 2015 FDA 483 Stevenson Industries Inc - Form 483, 2015-12-15
June, 2004 EIR Medtronic MiniMed, Inc. - EIR, 2007-12-21
January, 2007 EIR Brown, Stephen J, M.D. - EIR, 2007-01-05
March, 2002 EIR Abbott Laboratories Inc. - EIR, 2002-03-27
April, 2012 EIR Advanced Bionics, LLC - EIR, 2012-04-26
March, 2012 FDA 483 Freudenberg Medical, LLC - Form 483, 2012-03-27
May, 2006 FDA 483 Haemonetics Manufacturing Inc. - Form 483, 2006-05-23
November, 2013 EIR Advanced Sterilization Products - EIR, 2013-11-15
June, 2012 EIR Advanced Sterilization Products - EIR, 2012-06-21
December, 2009 EIR Advanced Bionics Llc - EIR, 2009-12-10
February, 2010 EIR Boston Scientific Neuromodulation Corporation - EIR, 2010-02-04
December, 2015 FDA 483 Iris Diagnostics - Form 483, 2015-12-16
August, 2006 FDA 483 Biolase Technology Inc - Form 483, 2006-08-17
October, 2000 FDA 483 OASIS Medical, Inc. - Form 483, 2000-10-13
September, 2008 FDA 483 ACCUTEST RESEARCH LABORATORIES ( I ) - Form 483, 2008-09-01
October, 2003 EIR Medtronic MiniMed, Inc. - EIR, 2003-10-09
December, 2001 FDA 483 Advanced Bionics Corp. - Form 483, 2001-12-21
December, 2002 FDA 483 Medical Electronic Devices Inc - Form 483, 2002-12-05
September, 2004 FDA 483 Advanced Bionics, LLC - Form 483, 2004-09-15
February, 2008 EIR Advanced Bionics Llc - EIR, 2008-02-27
December, 2001 FDA 483 Response Advanced Bionics, LLC - Form 483R, 2002-01-14
June, 2000 EIR B. Braun Medical Inc. - EIR, 2000-06-30
January, 2013 FDA 483 Freudenberg Medical, LLC - Form 483, 2013-01-18
June, 2010 FDA 483 Michael Dean Berger MD - Form 483, 2010-06-10
May, 2013 EIR Alcon Research, LLC - EIR, 2013-05-17
December, 2002 FDA 483 3M Unitek Corporation - Form 483, 2002-12-20
November, 2013 FDA 483 Advanced Sterilization Products - Form 483, 2013-11-15
June, 2000 EIR Sterigenics U.S., LLC - EIR, 2000-06-07
January, 2010 FDA 483 Spectrum Designs Inc. - Form 483, 2010-01-20
June, 2002 FDA 483 Amplimedical S.p.A. - Form 483, 2002-06-20
February, 2008 FDA 483 Advance Bionics Corp - Form 483, 2008-02-27
February, 2009 EIR Medtronic MiniMed, Inc. - EIR, 2009-02-04
January, 2002 FDA 483 Laerdal Medical A/S - Form 483, 2002-01-31
October, 2003 FDA 483 Medtronic Minimed - Form 483, 2003-10-09
October, 2003 FDA 483 Response Medtronic MiniMed, Inc. - Form 483R, 2003-10-23
November, 2010 FDA 483 LA Labs - Form 483, 2010-11-05
March, 2012 FDA 483 EDRD Enterprises Inc - Form 483, 2012-03-01
December, 2011 FDA 483 Philips Ultrasound, Inc. - Form 483, 2011-12-09
September, 2004 FDA 483 Response Advanced Bionics, LLC - Form 483R, 2004-10-18
March, 2014 EIR Rubin, Mark, G., MD - EIR, 2014-03-11
June, 2012 FDA 483 Advanced Sterilization Products - Form 483, 2012-06-21
September, 2010 EIR Medtronic MiniMed, Inc. - EIR, 2010-09-08
July, 2014 FDA 483 De Novo Software - Form 483, 2014-07-09
September, 2008 EIR ACCUTEST RESEARCH LABORATORIES ( I ) - EIR, 2008-10-16
October, 2010 FDA 483 Event Medical LTD - Form 483, 2010-10-08
July, 2013 FDA 483 KDL Precision Molding - Form 483, 2013-07-11

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