FDA Investigator Carla J Lundi

Carla J Lundi has conducted inspections on 353 sites in 12 countries as of 01 Jul 2021. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
353
Last Inspection Date:
01 Jul 2021
Investigator Role:
FDA Investigator
Redica ID:
100002567
Countries of Inspections:
United States of America, Austria, France, Germany, Canada, United Kingdom of Great Britain and Northern Ireland, Italy, Ireland, Sweden, Denmark, India, Switzerland
FDA Investigators that have inspected at least one site in common with Carla J Lundi:
Aaron J Adler, Adam R Cooke, Ademola O Daramola, Aimee K Contreras, Alan L Truong, Alan P Kurtzberg, Albinus M D'sa, Alexandra B Pitkin, Alexandria L Capuano, Aliza Chalapong Asawesna, Allen F Hall, Althea A Williams, Amalia C Himaya, Amanda E Lewin, PhD, Amanda L Fyles, Amir Alavi, Anastasia M Shields, Anderson, Andrea A Branche, Andrew K Haack, PhD, Andrew S Limson, Angele C Smith, Anissa M Cheung, Anita Narula, PhD, Anjali Shukla, PhD, Ann M Stewart, Ann Marie Montemurro, Ann Marie Schofield, Anna J Vickrey, Anna Lazar, Anthony G Emerson, Antonetta M Colacchio, April P Shaw, Arie C Menachem, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Arlene M Badillo, Arsen Karapetyan, Ashar P Parikh, Aurora Miha Trifanov, Azza Talaat, Babajide Michael Osunsanmi, Barbara D Wright, Barbara J Rincon, Barbara Janine Breithaupt, Barbara M Frazier, Barry Cherney, PhD, Belinda E Clifton, Bichsa T Tran, Bijoy Panicker, Binh T Nguyen, Blondell W Johnson, Bo Chi, PhD, Bonita S Chester, Bonnie I Needleman, Bradley E Tufto, Brenda W Uratani, PhD, Brentley S Collins, Brett R Havranek, Brian A Perkins, Brian J Ryan, Brian P Putz, Brien C Fox, Bruce H Mccullough, Bryan A Galvez, Burnell M Henry, Calvin B Koerner, Camerson E Moore, Candace Y Gomez Broughton, Carolina D Vasquez, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Catherine J Laufmann, Cathleen A Carr Sharpe, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Cecilia H Kieu, Celena Ngo, Charanjeet Jassal, Charisse K Green, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Chelsea N Sealey, Cheron M Portee, Christina A Miller, Christina C Santos, Christina V Santos, Christine W Twohy, Christopher D Leach, Christopher J Freebairn, Christopher M Hernandez, Christopher M Jenner, Christopher N Tran, Christopher R Czajka, Claire M Minden, Claudia Mperez Kasmarski, Comyar Shoghi, Concepcion Cruz, Jr, Crystal Monroy, Cynthia A Palmer, Cynthia Jim, CSO, Cynthia M Goudeau, Dale A Nyberg, Daniel J Lahar, Daniel J Roberts, Daniel R Solis, Daniel W Cline, Darren S Brown, Darrin E Davis, David G Whitman, David K Glasgow, David M Beltran, David Serrano, David Y Hernandez, Davinna Ligons, PhD, Davis, Deborah A Greco, Deborah Schmiel, PhD, Deborah W Hsu, Debra C Yamane, Debra J Fracassa, Dejon N Harris, Demitria J Xiradakis, Dena L Jacobs, Denise M Digiulio, Dennis Cantellops Paite, Dennis R Downer, Desiree C Iya, Diana M Rand, Diane Cvan Leeuwen, Diane L Raccasi, Diane R Weidley, Dipesh K Shah, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Don H Bark, PhD, Dongping Dai, PhD, Donna Ltartaglino Besone, Donna Mwilliams Hill, PhD, Douglas A Campbell, Dr. Chunchang Fang, Dr. Gang Wang, PhD, Dr. Willie Wilson, PhD, Dr. Zhihao Qiu (Peter), PhD, Durell L Giles, Dyana K Stone, Edmund F Mrak, Jr, Edwin Melendez, Eileen A Liu, Elaine A Bunch, Elizabeth A Brown, Elizabeth Ad Girard, Elizabeth Ll Edwards, Elizabeth P Mayer, Ellen J Kleintop, Ellen J Tave, Ellen N Stewart, Elsa A Kusumoto, Eric S Weilage, Esteban Beltran, Esther B Gamallo Herrera, Esther C Broner, PhD, Evelyn Wong, Farhana Khan, Finn A Slizza, Frances Namuswe, PhD, Francis A Guidry, Frederick L Fricke, Gabriel Craig, Gabriel M Guevarra, Gam S Zamil, Garciam, Gayle S Lawson, Gene D Arcy, George J Flynn, Geraldine D Sanders, Geraldine H Matining, Geraldine M Peregrin, Gilbert T Salud, Ginger M Sykes, Glen C Lawrence, Greg K Keshishyan, Gregory A Berg, Gulshan R Anand, Haley H Seymour, Haroon Vohra (NMI), Hasan A Irier, PhD, Heidy C Perales, Heika R Tait, Helen B Ricalde, Himanshu Gupta, PhD, Homero W Aguilar, Hossein Khorshidi, PhD, Hung H Do, MS, Iris C Macinnes, Israel Santiago, OCM, Ivis L Negron, Jacob W Reynolds, Jacobitz, Jacqueline Mdiaz Albertini, James A Barreto, James A Jagon, James B Arnett, James C Maclaughlin, James I Giefer, James L Dunnie, Jr, James M Timper Jr, James P Stallings, James R Fleckenstein, Jamie L Dion, Jamie M Du, Jane S Wernberg, Janet D Blount, Janet L Bowen, Jasmine N Thompson, Jay T Wong, Jazmine M Welcher, Jee Chung, PhD, Jeff M Uriarte, Jeffery A Johnson, Jeffrey A Sommers, Jeffrey P Raimondi, Jennie J Fan, Jennifer Gogley, Jennifer L Sheehan, Jennifer M Gogley, Jessica L Pressley, Jinnie Kokiatkulkij, Joan A Loreng, Joao Pedras Vasconcelos, PhD,, Jocelyn E Massey, Jocelyn E Sparks, Joe X Phillips, Joel D Hustedt, Joel Welch, PhD, Joey V Quitania, Jogy George, John A Gonzalez, John L Stevens, John R Myung, Jolanna A Norton, Jonetta I Collins, Jorge L Bertran, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose Martinez, Jr, Joseph C Yen, Joseph M Willems, Joseph R Haynes, Joseph S Fanelli, Joseph X Phillips, Joshua J Silvestri, Joshua P Wireman, Juan J Casado, Juanita Banuelos, Juanita P Versace, Juanj N Wu, Jude C Dikes, Judy C Nepsa, Julia Ventura, Julian C Hanson, Julie A Rorberg, Julie A Stocklin, Junho Pak, Justine Tomasso, Ka L Wong, Kaitlyn R Kornberg, Kalavati Suvarna, PhD, Karen A Wolnik, Karen E D'orazio, Karen M Cooper, Kari M Johansen, Katherine D Adams, Katherine E Jacobitz, Katherine Szestypalow, Kathleen R Jones, PhD, Kathryn E Ogger, Kathy Chiu, Kathy Kuo, Kawshalya Pathiraja, Keith P Iams, Kelley, Kellia N Hicks, Kelly S Mammen, Kelvin Cheung, Kelvin X Sanders, Kendra A Biddick, Kendra J Vieira, Kenneth H Williams, Kevin A Gonzalez, Kevin D Kallander, Kevin Lee, Kevin N Tran, Kevin P Foley, Kevin T Gerrity, Kham Phommachanh, Khoa Nathanv Tran, Kim Lthomas Cruse, Kimberly M Lichter, Kirtida Patel, Lacresha Menifee, Lakecha N Lewis, Lam, Lanita F Kelley, Latorie S Jones, Laura A Munsterman, Laura Fontan, MS, Laurenee L Adeoshun, Laurie A Haxel, Lawton W Lum, LCDR Chad N Thompson, LCDR Debra Emerson, Leonard H Lavi, Lequita M Mayhew, Lesley K Satterwhite, Li Hongpaul Yeh, PhD, Libia M Lugo, Lillian S Wu, Lilly O Barton, Liming Zhang, Linda F Murphy, Linda Linh N Adams, Linda Thai, Ling Yu L Liu, Lisa R Whitt, Lisa Shin, Lopez, Loretta J Jordan, Lori M Graham, Louis B Cencetti, LT Richard A Lyght, Lucas B Leake, Luis A Dasta, Luis Mburgos Medero, Luis P Torres, Lydia I Rosas Marty, Madushini Dharmasena, PhD, Mai X Huynh, Maida Henesian (NMI), Marcellinus D Dordunoo, Marcia B Williams, Marco A Solorio, Marco S Esteves, Marcus A Ray, Marcus F Yambot, Margaret M Annes, Maria C Agpaoa, Maria C Fermin, Maria Joselopez Barragan, PhD, Marie Falcone, Marie T Falcone, Marion Michaelis, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark A Tucker, Mark C Flotte, Mark C Saale, Mark R Mcclain, Mark W Babbitt, Mary Ewilkerson Brinsko, Maryam Tabatabaie, Maryna C Eichelberger, PhD, Matthew B Casale, Matthew J Johnson, Matthew R Clabeaux, Maurice M Sheehan, Maxyne T Lam, Mei Chen Mu, Meisha R Sampson, Meisha Waters, Melkamu Getie Kebtie, PhD, Mendoza O Wallace, Michael A Charles, Michael D Garcia, Michael D Kawalek, Michael F Schuette, Michael J Kuchta, Michael S Call, Michael Shanks, MS, Michael T Cyrus, Michele L Obert, Michele R Douglas, Michelle A Marsh, Michelle J Hines, Miguel A Martinez Perez, Mihaly S Ligmond, Minh D Phan, Mohsen Rajabi Abhari, FDA, Monica R Maxwell, Mra B Kamberem, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Muralidhara B Gavini, PhD, Myers, Nabeela J Chaudhry, Nancy L Rolli, Natalie J Ayoub, Natalie J Reese, Naveen B Walker, Nayan J Patel, Nelly N Tran, Nianna C Burns, Nicholas F Lyons, Nicholas L Hunt, Nicholas L Paulin, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Nicole A Lloyd, Omotunde O Osunsanmi, Otto D Vitillo, Pamela Y Lee, Parul M Patel, Patricia F Hughes, PhD, Patrick D Stone, MS, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paula A Trost, Pearl C Ozuruigbo, Peter Adams, PhD, Peter C Chow, Peter S Diak, Phal K Chhun, Philip F Istafanos, DMV, MS, Phillip L Toy, Prabhu P Raju, Prasad Peri, PhD, Rachel C Stanton, Ramon E Martinez, Randall N Johnson, Randy L Elsberry, Raymond T Oji, Raymond W Brullo, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard C Chiang, Richard L Friedman, Richard T Jensen, Richard W Tubb, Richmond K Yip, Robert C Coleman, Robert D Tollefsen, Robert Darius, Robert L Lewis, Jr, Robert M Barbosa, Rochelle A Rolnik, Rochelle K Kimmel, Roger F Zabinski, Rona Leblanc, PhD, Ronald L Koller, Ronda Leblanc, Rose Ashley, Rumany C Penn, PharmD, Russell K Riley, Ruth A Hoskins, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Samantha J Bradley, Samantha J Pinizzotto, D V M, Sandra A Boyd, Sandra A Hughes, Sandra L Shire, DMD, MPA, Sandra M Tallent, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sarah A Hassas, Sarah Arden, Sarah E Mcmullen, Sarah E Rhoades, Sarah Johnson, PhD, Scott J Matsuda, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sean P Desbrow, Selene T Torres, Seneca D Toms, Shannon B Ruelle, Sharon K Ferguson, Sharon K Thoma, PharmD, Sharon S Ho, Shelly M King, Sherri N Rohlf, MD, 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, Sripal R Mada, PhD, Stacie A Woods, Stanley Au, Stephanie A Slater, MS, Stephen D Brown, Stephen D Eich, Steven A Gonzales, Steven A Rubin, Steven D Kehoe, Steven E Porter, Jr, Steven Fong, MS, PhD, Steven M Weinman, Sudipan Karmakar, Sue Lee Chan, Sumit Sen, Sundy V Sedwick, Sunitha K Rajaram, PhD, Susan F Laska, MS, Susan K Bain, Susan M Jackson, Susan T Hadman, Susanna E Ford, Taichun Qin, PhD, Tajah L Blackburn, Tamala P Bogan, Tamala P Magee, Tamika White, Tamil Arasu, PhD, Teresa I Navas, Teresa T Cain, Terrance L Thomas, Terri L Dodds, Thao T Kwan, Thao X Tran, Thomas J Arista, Thomas R Beilke, Thomas W Gordon, Thuy T Nguyen, LCDR, Timothy P Lafave, Timothy T Kapsala, Todd M Stankewicz, Tony J Wu, Torrance J Slayton, Tracey T Duong, Trudy R Papson, Truong Xuan Nguyen (Andy), Tuan A Nguyen, Uttaniti Limchumroon (Tom), Valerie L Whipp, Vanessa R Muller, Vashti E Bocker, Veronica Fuentes, MS, Vickie J Kanion, Vickie L Anderson, Victor H Loo, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Virginia Carroll, PhD, Viviana Matta, Walden H Lee, Wayne E Seifert, Wenzheng Wendy Zhang, William Hallett, PhD, William J Leonard, Xiaohui Shen, Xiaokuang Lai, PhD, Xiaoping Guan, Xikui Chen (nmi), PhD, Xiomara Copeland, Yasamin Ameri, Yehualashet A Gessesse, Yiying E Chen, Youkeun Kim, Yumi J Hiramine, Yvette E Guillermo, Yvette Mlacour Davis, Yvins Dezan, Yvonne C Wilkes, Yvonne T Lacour, Yvonne Y Wu, Zachary A Bogorad, Zachary L Stamm, Zachary Ryan Harris, Zhong Li, PhD

Carla J Lundi's Documents

Publish Date Document Type Title
June, 2003 EIR Adamson Analytical Laboratories Inc - EIR, 2003-06-19
December, 2013 FDA 483 Bioduro LLC - Form 483, 2013-12-20
July, 2021 FDA 483 Revance Therapeutics, Inc. - Form 483, 2021-07-02
March, 2007 FDA 483 Watson Laboratories, Inc. - Form 483, 2007-03-09
June, 2013 FDA 483 Defender SD Manufacturing LLC - Form 483, 2013-06-18
May, 2015 FDA 483 Response Amgen, Inc - Form 483R, 2015-06-05
November, 2003 FDA 483 Sigdestad, Leonard (DVM) - Form 483, 2003-11-18
April, 2010 FDA 483 Best Formulations Inc. - Form 483, 2010-04-02
February, 2012 FDA 483 Glanbia Nutritionals - Form 483, 2012-02-02
March, 2013 FDA 483 Astellas Ireland Co., Ltd. - Form 483, 2013-03-08
July, 2011 FDA 483 FAREVA Unterach GmbH - Form 483, 2011-07-25
September, 2004 FDA 483 Haemonetics Manufacturing, Inc. - Form 483, 2004-09-09
June, 2013 EIR Teva Parenteral Medicines, Inc. - EIR, 2013-06-04
March, 2009 FDA 483 Watson Pharmaceuticals Inc - Form 483, 2009-03-23
December, 2013 EIR Bioduro LLC - EIR, 2013-12-20
July, 2015 FDA 483 Iso-Tex Diagnostics, Inc. - Form 483, 2015-07-10
December, 2010 FDA 483 Linda D. Bosserman - Form 483, 2011-01-06
October, 2002 EIR Bachem Americas, Inc. - EIR, 2002-10-11
May, 2016 FDA 483 Response B. Braun Medical Inc. - Form 483R, 2016-06-01
October, 2014 FDA 483 Siegfried PharmaChemikalien Minden GmbH - Form 483, 2014-10-24
December, 2014 FDA 483 Watson Laboratories, Inc. - Form 483, 2014-12-08
October, 2002 FDA 483 Bachem Americas, Inc. - Form 483, 2002-10-11
April, 2013 EIR Cardinal Health 414, LLC - EIR, 2013-04-30
February, 2016 FDA 483 Edmond Pharma Srl - Form 483, 2016-02-05
February, 2015 FDA 483 Westwood Laboratories, LLC. - Form 483, 2015-02-25
November, 2015 FDA 483 Discus Dental, LLC - Form 483, 2015-11-23
August, 2013 EIR Alliance Medical Products, Inc. (dba Siegfried Irvine) - EIR, 2013-08-16
July, 2011 FDA 483 Delpharm Tours - Form 483, 2011-07-07
September, 2003 FDA 483 Med-Pharmex, Inc - Form 483, 2003-09-12
August, 2012 EIR Gilead Sciences, Inc. - EIR, 2012-08-03
July, 2021 EIR Revance Therapeutics, Inc. - EIR, 2021-07-02
November, 2012 FDA 483 Watson Laboratories, Inc. - Form 483, 2012-11-26
December, 2002 FDA 483 Merit Pharmaceutical - Form 483, 2002-12-12
October, 2007 FDA 483 Watson Laboratories, Inc. - Form 483, 2007-10-26
January, 2011 FDA 483 Pfizer Health AB - Form 483, 2011-01-27
May, 2010 EIR Teva Parenteral Medicines, Inc. - EIR, 2010-05-14
January, 2016 FDA 483 A. Nelson & Co. Ltd. - Form 483, 2016-01-29
December, 2011 FDA 483 Innovacyn Inc. - Form 483, 2011-12-02
April, 2012 EIR Teva Parenteral Medicines, Inc. - EIR, 2012-04-24
May, 2013 FDA 483 Innovacyn Inc. - Form 483, 2013-05-16
May, 2016 EIR B. Braun Medical Inc. - EIR, 2016-05-11
March, 2017 FDA 483 Janssen Sciences Ireland UC - Form 483, 2017-03-03
September, 2017 EIR Bioreliance Ltd. - EIR, 2017-09-22
December, 2015 FDA 483 Paklab - Form 483, 2015-12-22
March, 2015 FDA 483 Gland Pharma Limited - Form 483, 2015-03-17
May, 2007 EIR James R. Dexter, M.D. - EIR, 2007-05-09
July, 2009 FDA 483 Truett Laboratories, Inc. - Form 483, 2009-07-10
September, 2004 FDA 483 Response Haemonetics Manufacturing, Inc. - Form 483R, 2004-11-09
February, 2009 EIR Kindeva Drug Delivery L.P. - EIR, 2009-02-02
January, 2004 FDA 483 GAR Laboratories Inc. - Form 483, 2004-01-05
September, 2009 FDA 483 Precision Science, Inc. - Form 483, 2009-09-18
August, 2013 FDA 483 Alliance Medical Products, Inc. (dba Siegfried Irvine) - Form 483, 2013-08-16
May, 2015 FDA 483 Amgen, Inc - Form 483, 2015-05-22
April, 2012 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2012-04-24
August, 2003 FDA 483 Grand Meadows, Inc. - Form 483, 2003-08-18
July, 2021 FDA 483 Response Revance Therapeutics, Inc. - Form 483R, 2021-07-02
April, 2009 FDA 483 Kirschbaum, M.D., Mark - Form 483, 2009-04-28
April, 2014 FDA 483 Watson Laboratories, Inc. - Form 483, 2014-04-21
September, 2014 FDA 483 International Medication Systems, Ltd. - Form 483, 2014-09-12
February, 2010 EIR Gilead Sciences, Inc. - EIR, 2010-02-12
October, 2015 EIR Prolacta Bioscience Inc - EIR, 2015-10-20
February, 2010 FDA 483 Gilead Sciences, Inc. - Form 483, 2010-02-12
May, 2015 EIR Amgen, Inc - EIR, 2015-05-22
May, 2004 FDA 483 Watson Laboratories, Inc. - Form 483, 2004-05-06
February, 2009 FDA 483 Kindeva Drug Delivery L.P. - Form 483, 2009-02-02
January, 2013 FDA 483 Multani, Gurmeet S., MD - Form 483, 2013-01-29
January, 2012 FDA 483 Kindeva Drug Delivery L.P. - Form 483, 2012-01-04
May, 2010 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2010-05-07
August, 2014 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2014-08-08
December, 2009 FDA 483 KC Pharmaceuticals, Inc. - Form 483, 2009-12-30
February, 2012 EIR Glanbia Nutritionals - EIR, 2012-02-02
October, 2004 FDA 483 Gilead Sciences, Inc. - Form 483, 2004-10-08
June, 2013 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2013-06-04
March, 2012 FDA 483 Sandoz GmbH - Form 483, 2012-03-16
June, 2012 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2012-06-28
April, 2013 FDA 483 Cardinal Health 414, LLC - Form 483, 2013-04-30
May, 2016 FDA 483 B. Braun Medical Inc. - Form 483, 2016-05-11
December, 2010 EIR Linda D. Bosserman - EIR, 2010-12-22

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