FDA Investigator Jacqueline Mdiaz Albertini

Jacqueline Mdiaz Albertini has conducted inspections on 161 sites in 14 countries as of 24 Feb 2022. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
161
Last Inspection Date:
24 Feb 2022
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Canada, Netherlands, Sweden, United States of America, France, Ireland, Switzerland, Denmark, Germany, United Kingdom of Great Britain and Northern Ireland, Spain, Italy, Austria, Belgium
FDA Investigators that have inspected at least one site in common with Jacqueline Mdiaz Albertini:
Aaron L Dunbar, Abby E Pelletier, Abdur Razzaque, Adam R Cooke, Ademola O Daramola, Aikaterini Alexaki, Aimee Cunningham, PhD, Alan L Truong, Alan R Condon, Alanna L Mussawwir Bias, Albert A Salvador, Alberto A Viciedo, Alexander M Kay, Alexey Khrenov, PhD, Alia Legaux, Alice S Tsao, Alicia Gilbert, Alicia M Mozzachio, Alla Kachko, PhD, Allen Lou, Allison A Rodriguez, Althea A Williams, Amber D Brodas, Amy H Ruble, Amy Kim, Amy L Singer, Amy M Cramer, Amy S Graf, Amy Wyan Mai, Ana P Barido, Ana S Cabrera, Anastasia G Lolas, Anastasia I Offordile, Anastasia M Shields, Andrew A Hoopes, Andrew A Leboeuf, Andrew Byrnes, PhD, Andrew C Chang, Andrew F Shrake, Andrew M Barlow, Andrey Sarafanov, PhD, Angela E Glenn, Angela Jourdain, Angela K Shen, Angela S Whatley, Anissa M Cheung, Anita Narula, PhD, Anita R Michael, Anita Verma, Ann L Demarco, Ann M Stewart, Ann Marie Montemurro, Ann Marie Schofield, Annemarie Bodnar, Annette A Ragosta, Anthony F Lorenzo, Anthony R Bucks, Antonina Aydanian, April L Young, Arduino Frankovic, Arie C Menachem, Arsen Karapetyan, Art O Czabaniuk, Ashar P Parikh, Ashley A Mutawakkil, Ashley J Burns, Ashley L Reiber, Astrida B Mattson, Atul J Agrawal, Audrey Thereset Uy, Azza Talaat, Barbara J Holladay, Barbara Janine Breithaupt, Barbara L Rellahan, PhD, Barbara M Frazier, Barbara T Carmichael, Bei Y He, Ben Du, Bijoy Panicker, Billy M Battles, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Bradley Dworak, PhD, Brandy D Brown, Brandy N Lepage, Brentley S Collins, Brett R Havranek, Brian D Nicholson, Brian R Yaun, Brian S Keefer, Brittany D Terhar, Brooke K Higgins, Brooke K Seeman, Bruce D Meade, Bruce H Mccullough, Bryan A Galvez, Burnell M Henry, Byungja E Marciante, Candace Y Gomez Broughton, Candice C Mandera, Candice J Cortes, Cara M Minelli, Carl A Huffman, III, Carl Lee, Carla A Norris, Carla J Lundi, Carlos M Gonzalez, Carmen Y Fisher, Carol L Rehkopf, Carolyn A Renshaw, Carolyn E Barney, Carolyn Yong, PhD, Carrie Ann Plucinski, Caryn M Everly, Caryn M Mcnab, Cassandra Overking, Catherine J Laufmann, Catherine V Quinlan, CDR Cecily Jones, CDR Donald Ertel, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, CDR Sean T Creighton, CDR Thomas R Berry, PPh, Chad E Schmear, Chad R Burger, Chaltu Nwakijra, Chao Ming Tsai, Charisse K Green, Charles I Ann, Charles Jewell, Charles R Bonapace, PhD, Chava Kimchi Sarfaty, PhD, Che Hungrobert Lee, Cherrie A Zachary, Cherry R Valerio, Chiang Syin, PhD, Chikako Torigoe, PhD, Christian D Lynch (CDL), Christina H Owens, Christina J Sauder, PhD, Christina K Theodorou, Christina Theodorou, Christina V Santos, Christine A Harman, PhD, Christine M Parmentier, Christine M Whitby, CSO, Christopher B May, Christopher D Leach, Christopher J Adams, Christopher R Czajka, Christopher T Middendorf, Claire M Minden, Cody D Rickman, Colleen F Hoyt, Concepcion Cruz, Jr, Connie P Rezendes, Craig A Garmendia, Craig D Zagata, Creighton T Tuzon, Cynthia A Harris, MD, RN, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia L Kelley, Cynthia White, Damaris Y Hernandez, Dan Grabicki, Danial S Hutchison, Daniel C Kearns, Daniel J Brown, Daniel J Grabicki, Daniel J Lahar, Daniel J Roberts, Daniel L Zheng, Daniel Lagasse, Daniel R Azar, Daniel T Lee, Darla J Christopher, Darrell E Luedtke, Darren S Morgan, Daryl A Dewoskin, Dave Hafner, Dave M Deroche, David A Oluwo, David E Bailey, David Galler Veety, David J Eide, David J Gasparovich, David J Hafner, David K Lau, David L Chon, David M Beltran, David Perkins, Dawn C Olenjack, Dawn E Barkans, Dawn L Wydner, Dawn M Braswell, Deborah B Nixon, Deborah J Parris, Deborah M Trout, Debra Bower, Debra I Love, Debra J Bennett, Debra L Pagano, Decarlos A Gomez, Demitria J Argiropoulos, Demitria J Xiradakis, Denis Gavin, PhD, Denise L Burosh, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Derek C Price, Destry M Sillivan, Devaughn Edwards, Deyaa Shaheen, Diana Kouiavskaia, Diane L Raccasi, Dianne S Alexander, Dino A Fiegelstock, Dmitriy V Volokhov, PhD, Dolores E Price, Dolores Harper, Don H Bark, PhD, Donald C Obenhuber, PhD, Donald L Lech, Donald L Myers, Dorothy W Lee, Douglas A Campbell, Douglas C Kovacs, Douglas F Frazier, Dov H Pluznik, PhD, Dr. Barbara D Paul, PhD, Dr. Gang Wang, PhD, Dr. Guang Gao, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Willie F Vann, PhD, Dr. Willie Wilson, PhD, Dr. Zhihao Qiu (Peter), PhD, Dr. Zhou Chen (nmi), MD PhD, Dusty F Snoeberg, Dwayne E Dollins, Edmund F Mrak, Jr, Edward A Brunt, Edward Deberry, Edward Patten, Edwin Melendez, Eileen A Liu, Ekaterina Allen, Elias N Paz Alonzo, Eliezar Ramos, Elizabeth B Griffin, Ellen Huang, Elmina E Akwo, Emest F Bizjak, Emilie E Kahn, Emily J Orban, Emmanuel A Dimaano, Jr, Ephrem Hunde, PhD, Eric J Cunningham, Eric M Mueller, PharmD, Eric M Padgett, Eric Peng, Eric Rothschild, Eric S Pittman, Erika M Wilkerson, Erika V Butler, Erin C Hill, Erin D Mccaffery, Erin Hill (EH), Erin L Mcfiren, Esra Toussaint, Eural E Porter, Evelyn Taha, Frank J Marciniak, Freddy Ortiz Colon, Frederick F Razzaghi, Freyja V Lynn, Fulton A Varner, Gabriel R Mclemore, Gamal A Norton, Gayle S Lawson, Gene D Arcy, Geneve M Maxwell, Geneve M Parks, George Pyramides, George T Allen, Jr, Gerald B Seaborn, Jr, Gerald D Bromley, Jr, Gerard Pde Leon, Gibbes Johnson, PhD, Gideon N Esuzor, Gilbert T Salud, Ginger M Sykes, Gloria E Parra, Gloria J Baca, MS, Grace Deneke, Grace E Mcnally, Grace I Cortesini, Graeme E Price, Gregory Price, Gregory R Dill, Guerlain Ulysse, Gwyn G Dickinson, Hai Lient Phung, Hailin Wang (Sheena), PhD, Hala L Selby, Hamet M Toure, PharmD MPH, Hanna L Potter, Haoheng Yan, PhD, Haruhiko Murata, Haydee B Romero, Hector A Carrero, Heika R Bounds, Heika R Tait, Helen B Ricalde, Helen R Bester, Helen Verdel, Helen Y Saccone, Henry K Lau, Himanshu Gupta, PhD, Holly Brevig, Holly M Scott, Howard Anderson, PhD, Humera T Khan, Irina Gaberman, Ivan E Reyes, J David Doleski, J Paul Kirwan, PhD, Jacob G Lutz, Jacob M Dyer, Jacqueline S Warner, James A Crim, James A Jagon, James C Lee, PharmD, James C Maclaughlin, James D Bridges, James E Keller, PhD, James I Giefer, James K Ireland, James L Dunnie, Jr, James L Finn, James M Mason, James P Stumpff, James R Evans, James R Montero, James W Plucinski, James W Whitney, Jamie L Dion, Janet B Abt, Janet L Bowen, Jared P Stevens, Jason D Abel, Jason F Chancey, Jawaid Hamid, Jay Slater, MD, Jay T Wong, Jazmine N Still, Jean Lhu Primmer, Jean M Kelahan, Jeanne M Morris, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey M Watson, Jennifer D Hollstrom, Jennifer L Bridgewater, Jennifer L Reed, Jennifer L Schmidt, Jennifer Macmillan, Jennifer Swisher, PhD, Jens Fricke, Jesse A Vazquez, Jessica Hankins, PhD, Jessica L Pressley, Jessie E Morris, Jianming Li, Jianyang Wang, Jie He, Jin Gao, Joan A Loreng, Joan Adamo, Joan Johnson, Joanne M Hajoway, Joanne Pryzbylik, Jocelyn C Turner, Joey V Quitania, John D Finkbohner, PhD, John F Cipollo, John Godshalk, John M Mcinnis, John M Seale, John P Mistler, John S Hartford, John Stansberry, PhD, Jonathan G Matrisciano, Jonathan Mclnnis, Jonathan W Chapman, Joohi Castelvetere, Jose Acruz Gonzalez, José E Meléndez, Jose Ohernandez Guzman, Jose R Hernandez, Joseph A Piechocki, Joseph F Mcginnis, RPh, Joseph F Owens, Joseph George, Joseph L Despins, PhD, Joseph R Lambert, Joseph T Madak, Joshua J Silvestri, Joy Rkozlowski Klena, Joyce A Rockwell, Juan A Morales, Juan L Arciniega, Jude C Dikes, Julianne C Mccullough, Julie D Bringger, Junho Pak, Justin A Boyd, Jyoti B Patel, PhD, Kaarin M Slotte, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Kara D Dobbin, Karen A Coleman, Karen E D'orazio, Karen Emasley Joseph, Karen L Kosar, Kari M Johansen, Karyn M Campbell, Katherine E Jacobitz, Katherine Szestypalow, Kathleen B Mihalik, Kathleen D Culver, Kathryn A Krentz, Kathryn Carbone, MD, Kathy E Noe, Kelli F Dobilas, Kelly I Anderson, Kelly K Nachtigal, Kelly N Kerr, Kelly R Lewis, Ken L Bowers, Kenneth M Gordon, Kenneth Nieves, Kenneth O Gee, PhD, Kevin A Gonzalez, Kevin D Kallander, Kevin J Matthews, Kevin Obrien, Kevin P Foley, Kham Phommachanh, Kimberley A Hoefen, Kimberly L Schultz, Kimberly M Bigler, Kinh Q Mac, Kirsten L Vadheim, PhD, Kristen D Evans, Kristin M Abaonza, Kristina J Donohue, Kristina L Conroy, Kristy A Zielny, Kristy E Zuroski, Kula N Jha, Kurt A Brorson, PhD, Kyran R Gibson, L Gnnmassimia Massimilla, PharmD, Lakisha M Williams, Lakshmi Narasimhan, PhD, Lance Mde Souza, MBA, Larry K Austin, Larry K Hampton, Lata C Mathew, PhD, Latorie S Jones, Laura Fontan, MS, Laura M Howard, Laura Schankweiler, Laureen F Kononen, Laurel A Beer, Lauren L Vajo, Lauren M Lilly, PhD, Laurie B Frazier, Laurie P Norwood, Lawrence Carter, III, Lawrence J Stringer, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Margaret Edi Gennaro, LCDR Randall L Morris, Leena Thomas, Lequita M Mayhew, Leslie A Paul, Leslie D Wagner, Lewis K Antwi, Li Li, Li Lu, PhD, Liatte Kreuger, PharmD, Lilia Bi, PhD, Lily Y Koo, Linda Thai, Lindan E Silvers, Lindsey Brown, PhD, Lindsey M Schwierjohann, Lindsey R Lyman, Lisa B Orr, Lisa K Capron, Lisa M Bellows, Lisa M Feola, Lisa Mathew, Lisa P Oakes, Lixia Cai, Lloyd D Payne, Lorelei S Jarrell, Loretta Nemchik, Lori A Holmquist, Lori Peters, Lori S Lawless, LT Daveta L Bailey, LT John M Mastalski, LTJG Bradley E Benasutti, LTJG Matthew R Palo, Lu Deng, Luella J Rossi, Lura D Baquero, Lydia S Chan, Lynda L Perry, PhD, Lynette P Salisbury, Lynne M Dwyer, Madelyn Renteria, Madushini Dharmasena, PhD, Makini Cobourne Duval, PhD, Maksim A Levenchuk, Malgorzata G Norton, PhD, Marc A Alston, Marc A Jackson, Jr, Marcelo O Mangalindan, Jr, Marcus A Ray, Marcus F Yambot, Margaret A Smithers, Margaret E Sarles, Margaret M Annes, Margaret Norton, Margaret Torres Vazquez, Maria Cecilia Tami, PhD, Maria Joselopez Barragan, PhD, Maria Pkelly Doggett, MBA, Marian E Major, PhD, Marian Majors, PhD, Marie B Buen Bigornia, Marie F Morin, Marijo B Kambere, PhD, Marion Michaelis, Marion W Nadeau, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark D Johnson, Mark E Frank, Mark R Mcclain, Mark W Babbitt, Marla A Cassidy, Marlene G Swider, Marlene L Davis, Marsha W Major, Martha Sullivan Myrick, Martha T Olone, Mary Davis Lopez, Mary E Farbman, PhD, Mary Jeanet Mcgarry, Mary T Carden, Maryna C Eichelberger, PhD, Mate Tolnay, Matthew A Spataro, Matthew J Gretkierewicz, Matthew M Schuckmann, Matthew R Dionne, Matthew R Sleeter, Maura Rooney, Maxine H Wong, Maxwell Van Tassell, PhD, Megan A Haggerty, Mei Chiung Huang (Jo), Meihong Liu, Melanie M Walker, Melba Trivera Clavell, Melissa D Ray, Melissa J Garcia, Melissa J Holz, Melissa J Ireland, Mercy O Quagraine, Miah I Schneider, Michael A Charles, Michael C Kennedy, PhD, Michael Curbarg, Michael D Omeara, Michael E Maselli, Michael F Skelly, PhD, Michael Gurbarg, Michael J Kuchta, Michael J Vardon, Michael L Chasey, Michael Merchlinsky, Michael R Goga, Michael Schmitt, Michael Serrano, Michael Shanks, MS, Michele Gottshall, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle Yclark Stuart, Mihaly S Ligmond, Mikel T Wright, Mikhail V Ovanesov, PhD, Milan S Blake, Milos Dokmanovic, PhD, Mindy M Chou, Mizanne E Lewis, Mohammad Heidaran, PhD, Monica Cburgos Garcia, Monica J Wilkins, Monica M Mcclure, Morris Sheldon, PhD, Mra Mcculloughj, Mra Munizn, Murthy Vkn Sikha, Myra K Casey, Nancy A Bellamy, Nancy E Kirschbaum, Nancy G Schmidt, Nancy Kirschbaum, PhD, Nancy L Neiger, Nancy L Rolli, Nancy T Waites, Natalya M Ananyeva, Nawab A Siddiqui, Nayan J Patel, Nebil A Oumer, Nicholas Obiri, PhD, Nicholas Z Lu, Nicole K Trudel, Niketa Patel, Nikisha M Bolden, Nimmy Mathews, Niraj R Mehta, PhD, Nisha C Patel, Nobuko H Katagiri, Norman K Starks, Norman Wong, Ogechi C Nna, Olga Simakova, PhD, Omotunde O Osunsanmi, Pankaj H Amin, Paola S Barnett, Paraluman S Leonin, Parul M Patel, Patricia A Cochran, Patricia A Mcilroy, Patricia D Gardner, Patricia F Hudson, Patricia F Hughes, PhD, Patricia H Dlugosz, Patrick C Klotzbuecher, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Paul W Keller, Paul W Moy, Paul Z Balcer, Paula A Trost, Peggy M Speight, Peng Zhou, Penny H Mccarver, Perry H Gambrell, Perry T Nichols, Pete Amin (Pankaj), Peter Abel, Peter Kessler, PhD, Peter R Lenahan, Philip A Klimkewicz, Philip F Istafanos, DMV, MS, Philip J Snoy, Phung Thien Nguyen, Pote Amin, Prabhu P Raju, Prajakta A Varadkar, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Qing Joanna Zhou, PhD, R Edwadebey Deberry, Rabia Ballica, PhD, Rachel C Harrington, Rachel T Evans, Rafael Padilla, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ram Sihag, PhD, Ramjay Vatsan, PhD, Ramon E Martinez, Randa Melhem, PhD, Randy L Clarida, Randy L Self, Raquel Gonzalez Rivera, Raymond R Roy, PhD, Raymond W Brullo, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Rodriguez, Regina T Brown, Reginald D Neal, Reyes Candau Chacon, PhD, Rhonda Alexander, Richard D Manney, Richard H Penta, Richard Heath Coats, Richard Jay Tucker, RS, Richard K Vogel, Richard L Friedman, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Richard T Riggie, Richard W Thornton, Ricki A Chase, Rita K Kabaso, Robert B Shibuya, MD, Robert C Coleman, Robert D Tollefsen, Robert J Ham, Robert J Maffei, Robert J Martin, Robert Jennings, Robert L Hummel, Robert L Stevenson, Robert M Barbosa, Robert R Barbosa, Robert Sausville, Robert W Fisher, Roberta W Cunningham, Robin Levis, PhD, Rochelle K Kimmel, Roger F Zabinski, Roman T Drews, PhD, Ronald E Lundquist, Ronald G Crawford, Ronald T Nowalk, Ronit Jolles Mazor, Rory K Geyer, Rose Ashley, Rumany C Penn, PharmD, Russell K Riley, S Lori Brown, PhD MPH, Salvatore N Randazzo, Salwa K Poole, Samina S Khan, Samuel W Labinjo, Sandra A Hughes, Sandra Kershaw, Sandra P White, Sang Bong Lee, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Sanket N Patel, Santiago Gallardo Johnson, Santos E Camara, Sarah Adella Fave, Sarah B Tanksley, Sarah E Rhoades, Sarah Forney, Sarah Kennett, PhD, Sarah M Meng, Sarah M Napier, Sarah Rhoades, Saundrea A Munroe, Scott A Golladay, Scott E Norris, Scott T Ballard, Sean R Marcsisin, Sena G Dissmeyer, Seneca D Toms, Seongeun Cho (Julia), PhD, Sergey S Akimov, Shafiq S Ahadi, Sharmila Shrestha, Sharon K Thoma, PharmD, Shawn E Larson, Sheila Dreher Lesnick, Sheldon Morris, Sheri L Stephenson, Sherry G Bous, Sheryl A Kochman, Shirley H Isbill, Shirley J Berryman, Shirshendu K Deb, PhD, Shuang Tang, Shwnji Susie Lee, Sidney B Priesmeyer, Simone E Pitts, Sinai I Davis, Solomon Yimam (SY), Sony Mathews, Sonya M Edmonds, Stacey S Degarmo, Stanley Au, Stephanie A Slater, MS, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen D Eich, Stephen R Souza, Steven A Rubin, Steven C Derrick, Steven C Madzo, Steven D Kehoe, Steven E Bowen, PhD, Steven Fong, MS, PhD, Steven J Thurber, Steven Kozlowski, MD, Steven L Carter, Steven P Donald, Sukhanya Jayachandra, Susan A Zullo, PhD, Susan F Laska, MS, Susan M Jackson, Susan M Turcovski, Susan O Oladeji, Susan P Bruederle, Susan T Hadman, Susan Yu, Susanna E Ford, Susanne M Richardson, MS RAC, Svetlana A Shestopal, Swati Verma, Tamala P Bogan, Tamala P Magee, Tamara Brey, Tamika D Cathey, Tammara A Newberry, Tammara A Stephens, Tammy L Chavis, Tania E Vizcaino, Tara L Breckenridge, Tara L Greene, Tawny L Colling, Temar Q Williams, Teresita C Mercado, Terri L Dodds, Terrig Thomas, PhD, Thai D Truong, That Q Dang, Theressa B Smith, Thomas A Peter, Thomas Finn, PhD, Thomas J Arista, Thomas J Cosgrove, Thomas R Withers, Thuy T Nguyen, LCDR, Tim Lee, Timothy K Lee, PhD, Timothy M Martin, Tina Buecklein, Tina M Pawlowski, Tina S Roecklein, Todd M Stankewicz, Tonnie L Carter, Torrance J Slayton, Toyin B Oladimeji, Tracey Asinjen Wiersma, Tracey L Harris, Tracy J Washington, Tracy K Li, Tracy R Ball, Travis S Bradley, Truong Xuan Nguyen (Andy), Tzanko Stantchev, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valerie Jgrecek Trinh, Verlinda A Narcisse, Veronica L Call, Vicky C Stoakes, Vijaya L Simhadri, Vioela J Caze, Viviana Matta, Vlada Matusovsky, Walsworth, Wayne E Seifert, Wayne J Meyer, Wayne T Smith, Wayne W Grundstrom, Wei Wang, PhD, Wella Wang, William D Tingley, Xianghong Jing (Emily), PhD, Xiao Wang, Xiaobin Lu (Victor), PhD, Xiaokuang Lai, PhD, Xiaoping Guan, Xiomara Copeland, Xiuju Lu, Xu Michael Di, PhD, Yasamin Ameri, Ying Xin Fan, PhD, Yiping Jia, Yonggang Wang, PhD, Youmin Wang, Yun Wu, PhD, Yvins Dezan, Yvonne M Santiago, Zachary L Miller, Zachary L Stamm, Ze Peng, Zenobia Taraporewala, Zhao Wang, PhD, Zhaohui Ye, Zhiping Ye, PhD, Zhong Li, PhD, Zhongren Wu, Zi Qiang Gu, Zonglin Hu, Zuben E Sauna, PhD

Jacqueline Mdiaz Albertini's Documents

Publish Date Document Type Title
October, 2003 FDA 483 Swedish Orphan Biovitrum AB (Publ) - Form 483, 2003-10-21
November, 2002 FDA 483 Kedrion Biopharma Inc. - Form 483, 2002-11-20
May, 2000 EIR Grifols Biologicals LLC - EIR, 2000-05-04
July, 2021 FDA 483 Immucor Inc - Form 483, 2021-07-30
August, 2021 FDA 483 Response Jubilant HollisterStier LLC - Form 483R, 2021-09-21
August, 2019 EIR Novartis Pharmaceuticals Corporation - EIR, 2019-08-21
September, 2003 FDA 483 Boehringer Ingelheim RCV GmbH & Co KG - Form 483, 2003-09-18
August, 2015 FDA 483 Sanofi Pasteur Limited - Form 483, 2015-08-10
August, 2021 FDA 483 Jubilant HollisterStier LLC - Form 483, 2021-08-31
September, 2017 FDA 483 Bavarian Nordic Berna GmbH - Form 483, 2017-09-22
April, 2003 EIR BAXALTA US INC. - EIR, 2003-04-18
October, 2014 EIR Wyeth Pharmaceutical Division of Wyeth Holdings LLC - EIR, 2014-10-31
August, 2010 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2010-08-18
June, 2019 FDA 483 Haematologic Technologies, LLC dba Prolytix - Form 483, 2019-06-27
May, 2016 FDA 483 Kedrion Biopharma Inc. - Form 483, 2016-05-05
August, 2019 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2019-08-21
January, 2017 FDA 483 UCB Pharma S.A. - Form 483, 2017-01-27
June, 2008 FDA 483 Response GlaxoSmithKline Biologicals SA - Form 483R, 2008-06-25
November, 2000 FDA 483 Grifols Therapeutics LLC - Form 483, 2000-11-17
March, 2001 EIR Grifols Therapeutics LLC - EIR, 2001-03-21
January, 2000 FDA 483 Immucor Inc - Form 483, 2000-01-25
July, 2013 FDA 483 Baxalta Manufacturing Sàrl - Form 483, 2013-07-12
February, 2013 EIR Antigen Laboratories Inc - EIR, 2013-02-15
January, 2004 FDA 483 MassBiologics - Form 483, 2004-01-15
June, 2004 FDA 483 Instituto Grifols, S.A. - Form 483, 2004-06-15
April, 2003 FDA 483 BAXALTA US INC. - Form 483, 2003-04-18
March, 2011 FDA 483 OKC Allergy Supplies, Inc. - Form 483, 2011-03-22
August, 2021 EIR Jubilant HollisterStier LLC - EIR, 2021-11-08
June, 2008 FDA 483 GlaxoSmithKline Biologicals SA - Form 483, 2008-06-25
November, 2000 FDA 483 Response Grifols Therapeutics LLC - Form 483R, 2001-01-12
May, 2000 FDA 483 Response Grifols Biologicals LLC - Form 483R, 2000-05-22
June, 2011 FDA 483 GlaxoSmithKline Vaccines Srl - Form 483, 2011-06-24
February, 2002 FDA 483 Wyeth-Lederle Vaccines - Form 483, 2002-02-01
January, 2009 EIR Crucell Switzerland AG - EIR, 2009-01-23
October, 2019 EIR Indivior Manufacturing LLC - EIR, 2019-10-18
August, 2018 FDA 483 Kedrion Biopharma Inc. - Form 483, 2018-08-29
October, 2003 EIR Janssen Biologics B.V. - EIR, 2003-12-29
November, 2000 EIR Grifols Therapeutics LLC - EIR, 2000-11-17
January, 2000 EIR Immucor Inc - EIR, 2000-01-25
May, 2000 FDA 483 Grifols Biologicals LLC - Form 483, 2000-05-04
June, 2002 FDA 483 GlaxoSmithKline Biologicals - Form 483, 2002-06-24
August, 2019 FDA 483 Response Novartis Pharmaceuticals Corporation - Form 483R, 2019-09-12
June, 2014 FDA 483 Pfizer Ireland Pharmaceuticals - Form 483, 2014-06-17
June, 2014 EIR Pfizer Ireland Pharmaceuticals - EIR, 2014-06-17
May, 2003 FDA 483 Medimmune Inc. - Form 483, 2003-05-16
August, 2000 FDA 483 IMTIX-Sangstat - Form 483, 2000-08-03
May, 2001 EIR Baxalta Belgium Manufacturing SA - EIR, 2001-05-02
March, 2016 FDA 483 ADMA Biologics, Inc - Form 483, 2016-03-03
May, 2009 FDA 483 ID Biomedical Corporation of Quebec - Form 483, 2009-05-28
October, 2014 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2014-10-31
June, 2012 FDA 483 Emergent BioSolutions Canada Inc - Form 483, 2012-06-21
January, 2008 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2008-01-17
May, 2003 FDA 483 Response AstraZeneca Pharmaceuticals LP - Form 483R, 2003-05-16
December, 2008 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2008-12-10
May, 2001 FDA 483 Response Baxalta Belgium Manufacturing SA - Form 483R, 2001-05-11
June, 2018 FDA 483 AstraZeneca Pharmaceuticals LP - Form 483, 2018-06-20
February, 2007 FDA 483 Genzyme Corporation - Form 483, 2007-02-14
July, 2018 FDA 483 LifeSouth Community Blood Centers, Inc - Form 483, 2018-07-24
March, 2002 FDA 483 IPSEN BIOPHARM LTD - Form 483, 2002-03-21
June, 2021 EIR Novartis Gene Therapies, Inc. - EIR, 2021-06-16
May, 2001 EIR Fareva Pau - EIR, 2001-06-06
July, 2017 FDA 483 Baxter Healthcare Corporation - Form 483, 2017-07-14
November, 2019 FDA 483 Response Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483R, 2019-12-18
February, 2020 FDA 483 LifeSouth Community Blood Centers, Inc - Form 483, 2020-02-27
December, 2021 FDA 483 Grifols Diagnostic Solutions Inc. - Form 483, 2021-12-07
February, 2002 EIR Pfizer, Inc. - EIR, 2002-02-01
August, 2011 EIR Bayer HealthCare LLC - EIR, 2011-08-12
June, 2021 FDA 483 Response Novartis Gene Therapies, Inc. - Form 483R, 2021-07-09
May, 2003 EIR AstraZeneca Pharmaceuticals LP - EIR, 2003-05-16
June, 2008 EIR GlaxoSmithKline Biologicals SA - EIR, 2008-06-25
May, 2001 FDA 483 Baxter Healthcare Corporation, Hyland Division - Form 483, 2001-05-02
March, 2001 FDA 483 Grifols Therapeutics LLC - Form 483, 2001-03-21
September, 2001 EIR Aventis Behring Gmbh - EIR, 2001-11-15
January, 2012 FDA 483 Octapharma AB - Form 483, 2012-01-19
March, 2022 FDA 483 Spark Therapeutics, Inc. - Form 483, 2022-03-04
June, 2005 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2005-06-16
August, 2001 EIR Nelco Vet, LLC - EIR, 2001-08-06
May, 2001 FDA 483 Aquitaine Pharm International - Form 483, 2001-05-11
May, 2013 FDA 483 New York Blood Center, Inc. - Form 483, 2013-05-07
March, 2016 EIR ADMA Biologics, Inc - EIR, 2016-03-03
May, 2008 FDA 483 Sanofi Pasteur Inc. - Form 483, 2008-05-16
June, 2001 EIR Hospira, Inc. - EIR, 2001-06-22
August, 2000 FDA 483 F. Hoffmann-La Roche AG - Form 483, 2000-08-08
November, 2018 FDA 483 Takeda Austria GmbH - Form 483, 2018-11-09
February, 2013 FDA 483 Antigen Laboratories Inc - Form 483, 2013-02-15
February, 2019 FDA 483 Avioq, Inc. - Form 483, 2019-02-27
June, 2001 FDA 483 Hospira, Inc. - Form 483, 2001-06-22
September, 2002 FDA 483 Response Emergent Biodefense Operations Lansing LLC - Form 483R, 2002-10-07
November, 2019 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2019-11-26
February, 2008 FDA 483 Alk-abello, Inc. - Form 483, 2008-02-13
October, 2003 FDA 483 Response Janssen Biologics B.V. - Form 483R, 2003-11-07
March, 2002 FDA 483 Millipore (U.K.) Ltd. - Form 483, 2002-03-12
September, 2002 FDA 483 Emergent Biodefense Operations Lansing LLC - Form 483, 2002-09-13
January, 2003 EIR Amgen, Inc. - EIR, 2003-01-24
June, 2021 FDA 483 Novartis Gene Therapies, Inc. - Form 483, 2021-06-16
June, 2011 EIR GlaxoSmithKline Vaccines Srl - EIR, 2011-06-24
January, 2017 EIR UCB Pharma S.A. - EIR, 2017-01-27
March, 2001 FDA 483 Response Grifols Therapeutics LLC - Form 483R, 2001-06-08
November, 2017 FDA 483 New York Blood Center, Inc. - Form 483, 2017-11-22
October, 2019 FDA 483 Indivior Manufacturing LLC - Form 483, 2019-10-18
November, 2019 EIR Wyeth Pharmaceutical Division of Wyeth Holdings LLC - EIR, 2019-11-26
July, 2019 EIR Sanofi - EIR, 2019-09-03
May, 2019 FDA 483 Protein Sciences Corporation - Form 483, 2019-05-31
October, 2003 FDA 483 Centocor BV - Form 483, 2003-10-30
November, 2014 EIR ENDO USA, Inc. - EIR, 2014-11-22
July, 2000 FDA 483 Aventis Pasteur SA - Form 483, 2000-07-27

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.

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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