FDA Investigator Burnell M Henry

Burnell M Henry has inspections in 19 countries as of 13 Oct 2023. Burnell M Henry has collaborated with a combinined 12385 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
151
Last Inspection Date:
13 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
Ireland, United States of America, United Kingdom of Great Britain and Northern Ireland, Switzerland, Singapore, Japan, Belgium, Italy, Canada, China, Germany, Austria, France, Spain, Portugal, Netherlands, Ukraine, Israel, Denmark
Co-Investigator(s):
A Williams, Aaron L Dunbar, Abby Lmozeke Baker, Abdur Rashid, Adam R Cooke, Ademola O Daramola, Aikaterini Alexaki, Aimee Cunningham, PhD, Albert F Peacock, PhD, Alia Legaux, Allison A Wellman, Amanda B Athey, Amy C Jordan, Amy Devlin, PhD, Amy H Ruble, Amy M Cramer, Amy Malla, Amy W Yan Mai, Ana S Cabrera, Anastasia G Lolas, Andrew A Leboeuf, Andrew Byrnes, PhD, Andrew M Barlow, Andrew W Harmon, Angela Jourdain, Angela K Shea, Angela K Shen, Angela S Whatley, Anissa M Cheung, Anita R Michael, Anita Verma, Ann L Demarco, Ann M Stewart, Ann Marie Montemurro, Ann Marie Schofield, Annemarie Bodnar, Annette A Ragosta, Anthony C Warchut, Anthony F Lorenzo, Arduino Frankovic, Arie C Menachem, Asamoah Asamoah, Ashley L Reiber, Atul J Agrawal, Ava M Bowman, Azza Talaat, Barbara J Rincon, Barbara M Frazier, Barbara T Carmichael, Benjamin J Smith, Bo Chi, PhD, Bo Liang, PhD, Bonita S Chester, Bradley Dworak, PhD, Brandon C Heitmeier, Brandon L Mariner, Brandy D Brown, Brenda L Reihing, Brenda P King, Brentley S Collins, Brently S Collins, Brian D Nicholson, Brian L Belz, Brian R Yaun, Brian R Yuan, Brittny C Cargo, Brooke K Higgins, Brooke K Seeman, Bruce H Mccullough, Bryce E Mansfield, Byungja E Marciante, Calvin B Koerner, Candice C Mandera, Candice J Cortes, Carla J Lundi, Carlos A Ortiz, Carolyn A Renshaw, Carolyn Yong, PhD, Carrie Ann Plucinski, Carrie L Doupnik, Caryn M Everly, Caryn M Mcnab, Cassandra Overking, Catherine J Laufmann, 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, Charisse K Green, Charles M Spyr, Charles R Cote, RIC, Chauncey A Stephens, Chava Kimchi Sarfaty, PhD, Cheng H Yen, Cherry R Valerio, Cheryl Llove Harris, Chestnut, Christian D Lynch (CDL), Christina Capacci Daniel, PhD, Christina D Lynch, Christina H Owens, Christina J Sauder, PhD, Christina K Theodorou, Christina V Santos, Christine A Harman, PhD, Christopher B May, Christopher D Leach, Christopher Downey, PhD, Claire M Minden, Clifton C Francis, Clinton J Lott, Concepcion Cruz, Jr, Constantin Y Philopoulos, Craig D Zagata, Creighton T Tuzon, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia Kelley, Daniel C Kearns, Darrell E Luedtke, Daryl A Dewoskin, David A Oluwo, David A Paterson, David Doleski, David Galler Veety, David J Gasparovich, David M Beltram, David M Beltran, David Perkins, David R Heiar, David S Cho, PhD, Dawn L Wydner, Dawn M Braswell, Deborah A Nebenzahl, Deborah J Parris, Deborah M Trout, Debra I Love, Dell S Moller, Denise L Burosh, Dennis Cantellops Paite, Dennis L Doupnik, Derek C Price, Derya C Coursey, Destry M Sillivan, Devaughn Edwards, Diana Kouiavskaia, Diane L Raccasi, Dino Feigelstock (DF), PhD, Dmitriy V Volokhov, PhD, Doan T Nguyen, PharmD, Dolores E Price, Donald C Obenhuber, PhD, Donald L Lech, Dorothy W Lee, Douglas A Campbell, Douglas C Kovacs, Douglas F Frazier, Dr. Andrew Shroke, Dr. Gang Wang, PhD, Dr. Guang Gao, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Willie F Vann, PhD, Dusty F Snoeberg, Edmund F Mrak, Jr, Edmund Fmrakjr S, Edward Deberry, Edward H Maticka, Edwin Melendez, Eileen A Liu, Ekaterina Allen, Eliezar Ramos, Elizabeth B Griffin, Ellen Huang, Ellen P Madigan, Emest F Bizjak, Emily J Orban, Emmanuel A Dimaano, Jr, Emmanuel Adu Gyamfi, Enrico Joset Mangahis, Eric J Cunningham, Eric L Dong, BS, Eric M Mueller, PharmD, Eric Peng, Eric S Pittman, Eric S Weilage, Erik W Koester, Erika M Wilkerson, Erika V Butler, Esra Toussaint, Eural E Porter, Evelyn Taha, Ewa Marszal, PhD, Fabian Chaparro, Fabian Nchaparro Rodriguez, Felice D'agnillo, PhD, Frank J Marciniak, Freddy Ortiz Colon, Fulton A Varner, Gabriel R Mclemore, Gam S Zamil, Gamal A Norton, Gene D Arcy, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Gerald D Bromley, Jr, Geraldine D Sanders, Gifford Whitehurst, Jr, Gilbert T Salud, Gloria E Parra, Gloria Parra, Grace Deneke, Grace I Cortesini, Gregory Price, Gregory R Dill, Gunther Bockhoudt, Gunther Boekhoudt, PhD, Hai Lien Phung, Hai Lien T Phung, Haruhiko Murata, Hasan A Irier, PhD, Haydee B Romero, Hector A Carrero, Helen B Ricalde, Helen R Bester, Holly Brevig, Humera Khan, Humera T Khan, Hyesuk Kong, Ibad U Khan, Ifueko Osemwota, Igbinoba, Irina Gaberman, Ivan E Reyes, J David Doleski, Jacqueline D Mitchell, Jacqueline Mdiaz Albertini, James A Crim, James C Maclaughlin, James E Keller, PhD, James L Kenney, DSc, James M Mason, James M Simpson, James P Lewis, Jr, James R Evans, James T Mccoy, James W Leonette, James W Plucinski, James W Whitney, Jaqueline Diaz Albertini, Jared P Stevens, Jason A Rossi, Jason D Abel, Jason F Chancey, Jason R Nickelsen, Javier E Santos, Jawaid Hamid, Jay Slater, MD, Jean Lhu Primmer, Jean M Kelahan, Jeanne M Morris, Jee Chung, PhD, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey P Raimondi, Jennifer L Bridgewater, Jennifer L Reed, Jennifer L Schmidt, Jennifer M Menendez, Jennifer Macmillan, Jesse A Vazquez, Jessica Hankins, PhD, Jessica L Pressley, Jie He, Joan A Loreng, Joan Johnson, Joanne Pryzbylik, Joanne T Gabay, Joey V Quitania, John D Finkbohner, PhD, John Dan, John F Cipollo, John M Mcinnis, John M Seale, John P Mistler, John S Hartford, John Stansberry, PhD, Johnetta F Walters, Johnson, Jonathan G Matrisciano, Jonathan W Chapman, Jose Acruz Gonzalez, Jose E Melendez, DDC, Jose O Hernandez, Jose R Hernandez, Joseph F Owens, Joseph George, Joseph Kutze, PhD, Joseph L Despins, PhD, Joyce A Rockwell, Juanita P Versace, Jude C Dikes, Julie D Bringger, Jun Park, PhD, June P Page, Junho Pak, Justin A Boyd, Justine M Corson, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Kara D Dobbin, Karen A Coleman, Karen Emasley Joseph, Kathleen D Culver, Kathleen R Jones, PhD, Kelly I Anderson, Kelly R Lewis, Kenneth Nieves, Keri U Walker, Kevin A Gonzalez, Kevin J Matthews, Kevin P Foley, Kewes, Kham Phommachanh, Kimberly Kroesen, Kimberly Lewandowski Walker, Kimberly M Bigler, Kinh Q Mac, Kirsten L Vadheim, PhD, Kirsten L Vodheim, PhD, Kristina J Donohue, Kristy A Zielny, Kyran R Gibson, Larry K Austin, Latorie S Jones, Laura Fontan, MS, Laura I Salazar, PhD, Laura M Howard, Laura Schankweiler, Laurel A Beer, Lauren L Vajo, Laurie B Frazier, Laurie P Norwood, Lawrence Harmon, Jr, Lawrence J Stringer, LCDR Debra Emerson, LCDR Randall L Morris, Leah M Andrews, Leena Thomas, Lei Zhang, PhD, Lequita M Mayhew, Leslie D Wagner, Lewis K Antwi, Li Hongpaul Yeh, PhD, Li Li, Libia M Lugo, Lily Y Koo, Linda N Thai, Linda R Kuchenthal, Linda Thai, Lindsey Brown, PhD, Lindsey M Schwierjohann, Lisa B Orr, Lisa Fecla, Lisa Feola, Lisa L Flores, Lisa M Bellows, Lisa M Parsons, Lisa Mathew, Lloyd D Payne, Logan T Williams, Lois K Gross, Lorelei S Jarrell, Loretta Nemchik, Lori A Holmquist, Lori J Silverstein, Lori P Peters, Lori S Lawless, LT Daveta L Bailey, LT Tamara J Henderson, LTJG Bradley E Benasutti, LTJG Matthew R Palo, Lu Deng, Lucas B Leake, Luella J Rossi, Luella Rossi, Luis M Burgos Medero, Maksim A Levenchuk, Malgorzata G Norton, Marc A Alston, Marc S Neubauer, Marcus A Ray, Margaret E Walsh, Margaret M Annes, Margaret Norton, Margaret Torres Vazquez, Maria Cecilia Tami, PhD, Maria Joselopez Barragan, PhD, Marian Majors, Marion Michaelis, Mariza M Jafary, Mark A Elengold, Mark E Frank, Mark R Mcclain, Marla A Cassidy, Martha T Olone, Marvin D Jones, Mary Alice Papdimitriou, Mary E Farbman, PhD, Mary P Padgett, Mary T Carden, Maryna C Eichelberger, PhD, Massoud Motamed, Matthew B Casale, Matthew D Silverman, Maxwell Van Tassell, PhD, Megan A Haggerty, Meihong Liu, Meisha R Sampson, Meisha Waters, Melissa J Garcia, Melissa J Holz, Melissa J Ireland, Mercy O Quagraine, Michael C Kennedy, PhD, Michael E Maselli, Michael L Chasey, Michael Merchlinsky, Michael R Goga, Michael R Klapal, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele M Falchek, Michele Perry Williams, Michelle M Noe, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Minh D Phan, Mizanne E Lewis, Mohammad Heidaran, PhD, Mohsen Rajabi Abhari, FDA, Monica E Murie, Monique C Lo, Morris Sheldon, PhD, Mra Davism, Mra Mcculloughj, Mra Munizn, Nabil Nakhoul, Nadeem I Chaudhry, Nailing Zhang, Nancy A Saxenian Emmons, Nancy L Neiger, Nancy T Waites, Natalya M Ananyeva, Nawab A Siddiqui, Neal L Adams, Nebil A Oumer, Nicholas A Violand, Nicholas L Paulin, Nicholas Obiri, PhD, Nicholas Z Lu, Nicole K Trudel, Nikisha M Bolden, Nimmy Mathews, Nobuko H Katagiri, Norman Wong, Olga Simakova, Olno Folgolstock, Omatunde O Osunsamni, Omotunde O Osunsanmi, Omotunder O Osunsanmi, Oumou Barry, Pankaj H Amin, Paola S Barnett, Parul M Patel, Parul Patel Sullivan, Patricia A Mcilroy, Patricia A Morrow, Patricia D Stahnke, Patricia F Hudson, Patricia Fhughes Troost, Patrick C Klotzbuecher, Patsy J Domingo, Paul A Bonneau, Paul L Figarole, Jr, Paul M Kawamoto, Paul W Keller, Paul W Moy, Paula A Trost, Peng Zhou, Penny H Mccarver, Peter Abel, Peter Kessler, PhD, Philip E Ake, Phung Thien Nguyen, Pote Amin, Prabhu P Raju, Pradip N Akolkar, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Qing Joanna Zhou, PhD, R Edwadebey Deberry, Rachael Lucinski, Rachael O Oyewole, Rachel C Harrington, Rachel T Evans, Rafael E Arroyo, Ralph A Erickson, Ram Sihag, PhD, Ramjay Vatsan, PhD, Randa Melhem, PhD, Randy L Clarida, Raquel Gonzalez, Raquel Gonzalez Rivera, Rashard A Knight, Raymond T Oji, Reba A Gates, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Parrilla, Rebecca Rodriguez, Rebecca T Davis, Regina Gibson Melton, Regina T Brown, Reginald D Neal, Reyes Candau Chacon, PhD, Richard D Manney, Richard E Needham, Richard H Penta, Richard Heath Coats, Richard Ledwidge (nmi), PhD, Richard T Riggie, Richard W Thornton, Robert C Coleman, Robert D Tollefsen, Robert J Maffei, Robert J Martin, Robert M Barbosa, Robert Sausville, Robert W Fisher, Robert W Jennings, Roberta W Cunningham, Robin Levis, PhD, Rocco C Black, Roger F Zabinski, Roman Drews, PhD, Rona A Leblanc, Ronald E Lundquist, Ronald T Nowalk, Rose Ashley, Rose M Ashley, Roy R Rinc, Russell J Glapion, Russell K Riley, S Lori Brown, PhD MPH, Sam Pepe, Samantha J Bradley, Samuel W Labinjo, Sang Bong Lee, Santos E Camara, Sarah B Tanksley, Sarah Forney, Sarah L Holliday, Sarah M Meng, Sarah M Napier, Satheesh Thomas, Scott E Norris, Scott T Ballard, Sean R Bryd, Sean R Marcsisin, Seneca D Toms, Seth A Mailhot, Shafiq S Ahadi, Sharon I Gundersen, Sharon K Thoma, PharmD, Shawn E Larson, Sheldon Morris, Shelley L Waring, Sheri L Stephenson, Sherry G Bous, Sheryl A Kochman, Shirley J Berryman, Shuang Tang, Shwnji Susie Lee, Sidney B Priesmeyer, Simone E Pitts, Solomon Yimam (SY), Sonya M Edmonds, Stacey S Degarmo, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen D Eich, Stephen R Souza, Steven A Gonzales, Steven A Rubin, Steven C Derrick, Steven D Dittert, Steven D Kehoe, Steven E Bowen, PhD, Steven Fong, MS, PhD, Steven J Thurber, Steven M Weinman, Steven P Donald, Sukhanya Jayachandra, Sukyoung Sohn, Susan F Laska, MS, Susan M Jackson, Susan M Turcovski, Susan O Oladeji, Susan P Bruederle, Susan W Ting, Susan Yu, Susan Zang, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Svetlana A Shestopal, Swati Verma, Tajah L Blackburn, Tamara Brey, Tamara M Casselman, Tamika D Cathey, Tammara A Newberry, Tammara A Stephens, Tammy L Chavis, Tara G Bizjak, Ted L Anderson, Temar Q Williams, Teresa I Navas, Teresita C Mercado, Terri L Dodds, Terrig Thomas, PhD, Thai D Truong, That Q Dang, Thomas E Friel, Thomas Finn, PhD, Thomas R Withers, Thomas Ryan Withers, Thuy T Nguyen, LCDR, Tim Lee, Timothy M Martin, Tina Buecklein, Tina S Roecklein, Tod J Merkel, Todd M Stankewicz, Tonya R Johnson, Torrance J Slayton, Toyin B Oladimeji, Tracy J Washington, Tracy R Ball, Trang N Cox, Travis S Bradley, Troy C Quander, Truong Xuan Nguyen (Andy), Unnee Ranjan, Valerie Grecek Trinh, Valerie J Grecek Trinh, Veronica Fuentes, MS, Veronica L Call, Vesna V Stanoyevitch, Victor J Gangi, Vioela J Caze, Viviana Matta, Viviana R Ramirez, Walter Lange, Wanda E Pagan, PhD, Wayne E Seifert, Weedb, Wei Wang, PhD, Wella Wang, William J Leonard, Xiaojun Yan, Xiaokuang Lai, PhD, Yanming An, PhD, Yasamin Ameri, Yiping Jia, Yonggang Wang, PhD, Youmin Wang, Yumi J Hiramine, Yvins Dezan, Zada L Giles, Ze Peng, Zhao Wang, PhD, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhongren Wu, Zhpping Ye, Zuben E Sauna, PhD

Burnell M Henry's Documents

Publish Date Document Type Title
August, 2010 FDA 483 BAXALTA US INC. - Form 483, 2010-08-27
June, 2007 EIR GlaxoSmithKline LLC - EIR, 2007-06-12
December, 2016 EIR Alk-abello, Inc. - EIR, 2016-12-21
February, 2019 EIR Novartis Gene Therapies, Inc. - EIR, 2019-02-15
June, 2014 FDA 483 CSL Behring AG - Form 483, 2014-06-19
December, 2009 FDA 483 American National Red Cross - Form 483, 2009-12-04
March, 2015 FDA 483 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. - Form 483, 2015-03-05
February, 2012 FDA 483 CSL Behring AG - Form 483, 2012-02-02
May, 2015 FDA 483 GlaxoSmithKline Biologicals - Form 483, 2015-05-19
December, 2016 FDA 483 Alk-abello, Inc. - Form 483, 2016-12-21
May, 2017 FDA 483 Emergent BioSolutions Canada Inc - Form 483, 2017-05-16
November, 2021 FDA 483 Baxter Pharmaceutical Solutions LLC - Form 483, 2021-11-10
February, 2009 FDA 483 Zibo Xinhua-Perrigo Pharmaceutical Co., Ltd - Form 483, 2009-02-20
June, 2018 FDA 483 BioConnection B.V. - Form 483, 2018-06-01
November, 2017 FDA 483 Greer Laboratories, Inc. - Form 483, 2017-11-22
August, 2006 FDA 483 Kiel Laboratories Inc - Form 483, 2006-08-14
May, 2013 FDA 483 Emergent Biodefense Operations Lansing LLC - Form 483, 2013-05-02
May, 2013 FDA 483 CAF-DAF scrl - Form 483, 2013-05-23
November, 2014 FDA 483 Prothya Biosolutions Netherlands B.V. - Form 483, 2014-11-20
November, 2011 FDA 483 Alk-abello A/s - Form 483, 2011-11-21
April, 2018 FDA 483 Response Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483R, 2018-05-10
October, 2012 EIR Fibrocell Technologies, Inc. - EIR, 2012-10-12
November, 2021 EIR Baxter Pharmaceutical Solutions LLC - EIR, 2021-11-10
September, 2019 FDA 483 Takeda - Form 483, 2019-09-25
January, 2010 FDA 483 CSL Behring AG - Form 483, 2010-01-19
September, 2013 EIR Baxter Healthcare Corporation - EIR, 2013-09-17
December, 2018 FDA 483 MP Biomedicals Asia Pacific Ptd Ltd - Form 483, 2018-12-14
April, 2022 FDA 483 Dendreon Pharmaceuticals LLC - Form 483, 2022-04-21
May, 2006 FDA 483 TriRx Huntsville Pharmaceutical Services, LLC - Form 483, 2006-05-19
March, 2020 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2020-03-04
September, 2017 FDA 483 Bavarian Nordic Berna GmbH - Form 483, 2017-09-22
January, 2008 FDA 483 IVAX Pharmaceuticals Inc - Form 483, 2008-01-31
May, 2018 EIR Tjoapack Netherlands BV - EIR, 2018-05-25
November, 2018 EIR RxCrossroads 3PL LLC - EIR, 2018-11-15
February, 2022 EIR Merck Teknika LLC - EIR, 2022-02-23
February, 2020 FDA 483 New York Blood Center, Inc. - Form 483, 2020-02-11
March, 2011 FDA 483 OKC Allergy Supplies, Inc. - Form 483, 2011-03-22
June, 2011 FDA 483 Catalent Belgium SA - Form 483, 2011-06-10
October, 2021 EIR Eurofins Lancaster Laboratories, Inc - EIR, 2021-11-23
August, 2023 FDA 483 Dendreon Pharmaceuticals LLC - Form 483, 2023-08-10
August, 2021 EIR ADMA Biologics, Inc - EIR, 2021-08-12
March, 2023 FDA 483 Alk-abello, Inc. - Form 483, 2023-03-09
June, 2016 FDA 483 Lonza Walkersville, Inc. - Form 483, 2016-06-09
March, 2013 EIR Merck Teknika LLC - EIR, 2013-03-25
June, 2013 FDA 483 Prothya Biosolutions Netherlands B.V. - Form 483, 2013-06-04
January, 2012 EIR Genzyme Flanders - EIR, 2012-01-24
August, 2015 FDA 483 Greer Laboratories, Inc. - Form 483, 2015-08-27
January, 2013 EIR Barr Laboratories Inc. - EIR, 2013-01-18
May, 2017 FDA 483 Response Emergent BioSolutions Canada Inc - Form 483R, 2017-06-06
January, 2008 EIR IVAX Pharmaceuticals Inc - EIR, 2008-01-31
November, 2017 FDA 483 Response Greer Laboratories, Inc. - Form 483R, 2017-12-15
November, 2011 FDA 483 SmartPractice Denmark ApS - Form 483, 2011-11-11
August, 2015 FDA 483 Sanofi Pasteur Limited - Form 483, 2015-08-10
June, 2018 EIR BioConnection B.V. - EIR, 2018-06-01
October, 2018 FDA 483 Dendreon Pharmaceuticals LLC - Form 483, 2018-10-22
November, 2014 FDA 483 CAF-DAF scrl - Form 483, 2014-11-07
May, 2017 EIR Emergent BioSolutions Canada Inc - EIR, 2017-05-16
February, 2011 FDA 483 CSL Behring L.L.C. - Form 483, 2011-02-03
February, 2019 EIR Novartis Gene Therapies, Inc. - EIR, 2019-02-15
June, 2017 FDA 483 Seqirus Vaccines Limited - Form 483, 2017-06-30
August, 2015 EIR Greer Laboratories, Inc. - EIR, 2015-08-27
April, 2014 FDA 483 Bio-Rad Laboratories, Inc. - Form 483, 2014-04-23
June, 2021 FDA 483 Kedrion Biopharma Inc. - Form 483, 2021-06-25
January, 2010 FDA 483 Boehringer Ingelheim RCV GmbH & Co KG - Form 483, 2010-01-28
July, 2018 FDA 483 Sanofi Chimie - Form 483, 2018-07-18
March, 2017 FDA 483 Biogen MA Inc. - Form 483, 2017-03-23
February, 2019 FDA 483 Novartis Gene Therapies, Inc. - Form 483, 2019-02-08
June, 2014 EIR GSK Vaccines GmbH - EIR, 2014-06-30
November, 2013 FDA 483 Greer Laboratories, Inc. - Form 483, 2013-11-15
May, 2019 FDA 483 Sanofi Pasteur Limited - Form 483, 2019-05-24
November, 2021 FDA 483 Response Baxter Pharmaceutical Solutions LLC - Form 483R, 2021-11-10
July, 2021 FDA 483 Immucor Inc - Form 483, 2021-07-30
August, 2021 FDA 483 ADMA Biologics, Inc - Form 483, 2021-08-12
April, 2010 FDA 483 Emergent BioSolutions Canada Inc - Form 483, 2010-04-22
February, 2019 FDA 483 Response Novartis Gene Therapies, Inc. - Form 483R, 2019-03-12
March, 2013 FDA 483 Merck Teknika LLC - Form 483, 2013-03-25
November, 2012 FDA 483 OMRIX BIOPHARMACEUTICALS LTD - Form 483, 2012-11-05
September, 2012 FDA 483 BAXALTA US INC. - Form 483, 2012-09-20
September, 2013 FDA 483 Baxter Healthcare Corporation - Form 483, 2013-09-17
May, 2018 FDA 483 Tjoapack Netherlands BV - Form 483, 2018-05-25
January, 2016 FDA 483 Dendreon Pharmaceuticals LLC - Form 483, 2016-01-22
May, 2011 FDA 483 CAF-DAF scrl - Form 483, 2011-05-31
May, 2006 FDA 483 Response TriRx Huntsville Pharmaceutical Services, LLC - Form 483R, 2006-06-15
January, 2017 FDA 483 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. - Form 483, 2017-01-17
January, 2015 FDA 483 Dendreon Pharmaceuticals LLC - Form 483, 2015-01-09
April, 2019 FDA 483 Corixa Corporation - Form 483, 2019-04-15
September, 2019 FDA 483 Greer Laboratories, Inc. - Form 483, 2019-09-11
May, 2012 FDA 483 ADMA Biologics, Inc - Form 483, 2012-05-17
April, 2018 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2018-04-19
November, 2022 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2022-11-18
April, 2019 FDA 483 Corixa Corporation - Form 483, 2019-04-15

Experience Redica System's 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