FDA Investigator LCDR Debra Emerson

LCDR Debra Emerson has conducted inspections on 229 sites in 12 countries as of 12 May 2022. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
229
Last Inspection Date:
12 May 2022
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
United States of America, Canada, Norway, France, Switzerland, Germany, Italy, Belgium, Denmark, Austria, Netherlands, Sweden
FDA Investigators that have inspected at least one site in common with LCDR Debra Emerson:
Aaron L Dunbar, Aaron L Morris, Abby E Pelletier, Abdur Rafay Shareef, Ademola O Daramola, Aimee Cunningham, PhD, Alan L Truong, Alan R Condon, Alexander M Kay, Alexey Khrenov, PhD, Alice C Silva, Alice Canty, Alissa E Berryman, Allison A Rodriguez, Almaris N Alonso, Alois P Provost, Althea A Williams, Amber G Wardwell, Amy C Jordan, Amy Devlin, PhD, Ana P Barido, Ana S Cabrera, Andrew Byrnes, PhD, Andrew F Shrake, Andrew M Barlow, Andrey Sarafanov, PhD, Angela E Glenn, Anh M Lac, Anissa M Cheung, Anita Narula, PhD, Anita R Michael, Anjali Shukla, PhD, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Anne E Carpenter, Annemarie Bodnar, Annet R Rajan, Anthony A Charity, Anthony C Warchut, Anthony F Lorenzo, Anthony P Costello, Anthony W Lee, Anthony W Thomas, April L Young, Arie C Menachem, Arsen Karapetyan, Arthur T Ogdahl, Asamoah Asamoah, Ashar P Parikh, Ashley J Burns, Ashley L Reiber, Ashley M Whitehurst, Astrida B Mattson, Atricia L Irons, Azza Talaat, Barbara Janine Breithaupt, Barbara M Frazier, Bijoy Panicker, Binh T Nguyen, Bo Chi, PhD, Bo Liang, PhD, Bonita S Chester, Bradley Dworak, PhD, Brandy N Lepage, Brenda P King, Brenda W Uratani, PhD, Brentley S Collins, Brian D Nicholson, Brian L Belz, Brian R Yaun, Brooke K Higgins, Brooke K Seeman, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Camerson E Moore, Candace Y Gomez Broughton, Candice C Mandera, Candice J Cortes, Carla C Cummins, Carla C Tuite, Carla J Lundi, Carlos Chavez, Carol L Rehkopf, Carole L Jones, Carolyn A Renshaw, Carrie Ann Plucinski, Carrie L Doupnik, Caryn M Mcnab, Cassandra L Abellard, Cassandra Overking, CDR Donald Ertel, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, CDR Sean T Creighton, Chad R Burger, Charisse K Green, Charles I Ann, Charles L Larson, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Charlotte Hinkle, Chava Kimchi Sarfaty, PhD, Chiang Syin, PhD, Christian D Lynch (CDL), Christina Capacci Daniel, PhD, Christine A Harman, PhD, Christopher D Leach, Christopher Downey, PhD, Christopher K Vantwuyver, Christopher M Elliott, Christopher R Czajka, Claire M Minden, Cody D Rickman, Concepcion Cruz, Jr, Connie P Rezendes, Constance Desimone, Courtney N Long, Creighton T Tuzon, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia M Goudeau, Cynthia Whitmarsh, Daniel C Kearns, Danielle S Pearson, Darin S Wiegers, Darla J Christopher, Daryl A Dewoskin, David A Oluwo, David J Hafner, David M Beltran, David P Vanhouten, David Perkins, Dawn E Barkans, Dawn L Wydner, Dawn M Braswell, Deborah J Parris, Deborah M Trout, Debra I Love, Dennis Cantellops Paite, Dennis L Doupnik, Derek S Smith, PhD, Destry M Sillivan, Diane C Thibodeau, Diane L Raccasi, Diane M Prince, Diane T Bargo, Diane T O'brien, Dien N Nguyen, Dino A Fiegelstock, Divek R Jumani, Doan T Nguyen, PharmD, Dolores E Price, Dolores Harper, Don H Bark, PhD, Donahue, Donald C Obenhuber, PhD, Dongping Dai, PhD, Dorothy W Lee, Douglas A Campbell, Douglas C Kovacs, Douglas F Frazier, Douglas S Joslin, Dr. Gang Wang, PhD, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Dr. Willie F Vann, PhD, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Eduardo L Rodriguez, Edward J Janik, Edwin Melendez, Eileen A Liu, Ekaterina Allen, Elias N Paz Alonzo, Eliezar Ramos, Elise L Mcdevitt, Elizabeth B Griffin, Elizabeth D Connell, Elizabeth Ll Edwards, Ellen Huang, Ellen P Madigan, Emest F Bizjak, Emmanuel Adu Gyamfi, PhD, Ephrem Hunde, PhD, Eric L Dong, BS, Erin D Mccaffery, Erin P Conlin, Fabian Nchaparro Rodriguez, Francis A Guidry, Frank J Koch, Frank J Marciniak, Frederick F Razzaghi, Gam S Zamil, Garry H Stewart, Gary J Hagan, Gene D Arcy, George Pyramides, George T Allen, Jr, Gerald B Seaborn, Jr, Geraldine D Sanders, Gerard Pde Leon, Gifford Whitehurst, Jr, Ginger M Sykes, Gloria J Baca, MS, Grace I Cortesini, Gregory Price, Gunther Boekhoudt, PhD, Gwyn G Dickinson, Haley H Seymour, Harlan J Howard, Haruhiko Murata, Heika R Bounds, Heika R Tait, Helen B Ricalde, Helen R Bester, Hongna Wang, Hugh M Mcclure, II, Humera T Khan, Ivy E Sweeney, J David Doleski, Jacek Cieslak, PhD, Jack Ragheb, Jacqueline Mdiaz Albertini, James C Maclaughlin, James E Keller, PhD, James L Dunnie, Jr, James L Kenney, DSc, James Norman, James P Finn, James P Mcreavey, James W Leonette, James W Whitney, Jamie S Mathews, Janet A Rajan, Janet L Bowen, Jason A Rossi, Jason F Chancey, Javier O Vega, Jawaid Hamid, Jay M Patria, Jayaleka J Amarasinghe, Jean Lhu Primmer, Jean M Kelahan, Jeanne M Morris, Jee Chung, PhD, Jeffrey D Meng, Jennifer D Hollstrom, Jennifer L Bridgewater, Jennifer L Reed, Jennifer L Schmidt, Jennifer Macmillan, Jennifer T Szymanski, Jeremy W Rotton, Jessica Chery, Jessica D Spellman, Jessica Hankins, PhD, Jessica L Pressley, Jianming Li, Jie He, Joan A Loreng, Joanne E King, Joanne Pryzbylik, Joey V Quitania, John A Gonzalez, John A Sciacchitano, John F Cipollo, John Godshalk, John J Thibodeau, John L Zaccone, John M Mcinnis, John M Seale, John P Mistler, John P Shelton, John S Hartford, Jonah S Ufferfilge, Jonathan B Lewis, Jonathan G Matrisciano, Jonathan Mclnnis, Jonathan W Chapman, Jorge L Guadalupe, Jose A Lopez, Jose A Torres, Jose Acruz Gonzalez, José E Meléndez, Jose Martinez, Jr, Jose R Hernandez, Joseph George, Joseph H Procopio, Jr, Joshua J Silvestri, Joshua P Wireman, Joyce A Kellett, Joyce A Rockwell, Julie D Bringger, Junho Pak, Justin A Boyd, Justine M Corson, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Karen A Briggs, Karen Mcnabb Noon, Kari M Johansen, Katherine D Adams, Katherine E Jacobitz, Kathleen A Sousa, Kathleen E Mcafoose, Kathleen M Curry, Kathleen M Jordan, Kathleen R Jones, PhD, Kathryn A Krentz, Katie L Penno, Kelly I Anderson, Kelly L Anderson, Kelly R Lewis, Kenneth H Williams, Kenneth Nieves, Kenneth O Gee, PhD, Kent A Conforti, Kent C Faul, Kevin D Kallander, Kevin J Matthews, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kimberly M Bigler, Kirsten L Vadheim, PhD, Kristen D Evans, Kristin M Abaonza, Kristina J Donohue, Kristina M Joyce, Kristy A Zielny, Kula N Jha, L Norwood, Larry K Austin, Latorie S Jones, Laura Fontan, MS, Laurel A Beer, Lauren M Lawrance, Laurie B Frazier, Laurie Graham, Lawrence Harmon, Jr, Lawrence J Stringer, LCDR Randall L Morris, Leiyun Boone, PhD, Leo B Zadecky, Leslie D Wagner, Lewis K Antwi, Li Yun Huang, Libia M Lugo, Linda L Green, Linda M Cheny, Linda Thai, Lindsey R Lyman, Lisa D Cash, Lisa K Capron, Liz M Otero, Lloyd D Payne, Lorayne A Mcguinness, Lori A Holmquist, Lori M Newman, Lori S Lawless, Louis Christy, LTJG Bradley E Benasutti, Lu Deng, Lura D Baquero, Lydia I Rosas Marty, Lydia S Chan, Lynda L Perry, PhD, Lynne M Dwyer, M Pedgen, Malgorzata G Norton, PhD, Marcellinus D Dordunoo, Marcus A Ray, Margaret E Walsh, Margaret L Bolte, Margaret M Annes, Margaret M Sands, Maria Pkelly Doggett, MBA, Marie A Fadden, Marijo B Kambere, PhD, Marilyn Welchenbach, Marion Michaelis, Mariza M Jafary, Mark C Lookabaugh, Mark E Farrell, Mark E Parmon, Mark R Mcclain, Mark W Babbitt, Marlene G Swider, Martha T Olone, Martin J Guardia, Marvin D Jones, Mary Jeanet Mcgarry, Mary P Padgett, Mary T Carden, Maryam Tabatabaie, Matthew C Watson, Matthew D Silverman, Maura Rooney, Maxine H Wong, Maxwell Van Tassell, PhD, Maya M Davis, Megan A Haggerty, Mei Chiung Huang (Jo), Meihong Liu, Meisha R Sampson, Meisha Waters, Melissa J Garcia, Melissa J Holz, Melissa J Ireland, Meredith L Miller, Merideth K Rose, Michael C Kennedy, PhD, Michael J Casey, Michael J Vardon, Michael L Casner, Michael O Idowu, Michael P Anthony, Michael P Sheehan, Michael P Sweeney, Michael R Goga, Michael R Klapal, Michael Schmitt, Michele L Forster, PhD, Michele L Obert, Michelle M Noe Varga, Michelle Yclark Stuart, Mihaly S Ligmond, Mikel T Wright, Mikhail V Ovanesov, PhD, Monica J Wilkins, Monique C Lo, Mra B Kamberem, Mra Davism, Mra Mcculloughj, Nabil Nakhoul, Nadeem I Chaudhry, Nailing Zhang, Nancy Kirschbaum, PhD, Nancy T Waites, Nasser Yazdani, DVM, MPH, Nawab A Siddiqui, Neal L Adams, Nealie C Newberger, Nebil A Oumer, Nicholas A Violand, Nicholas L Paulin, Nichole B Murphy, Nicole A Lloyd, Nicole K Trudel, Nicole M Li, Obinna R Echeozo, Ogechi C Nna, Olga Simakova, PhD, Omotunde O Osunsanmi, Paige R Mccoy, Pamela L Lee, Pamela L Ogonowski, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia F Hughes, PhD, Patrick M Regan, Patsy J Domingo, Paul A Bonneau, Paul E Stein, Paul L Bellamy, Paul P Geraci, Paula A Trost, Paula M Laplant, Perry H Gambrell, Pete Amin (Pankaj), Peter Kessler, PhD, Philip F Istafanos, DMV, MS, Philip Kreiter, Phillip E Mclaughlin, Pote Amin, Prabhu P Raju, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Qing Joanna Zhou, PhD, Quyen T Tran, Rabia Ballica, PhD, Rachael O Oyewole, Rachel C Harrington, Ralph A Erickson, Ramcharan S Khalsa, Ramjay Vatsan, PhD, Ramon E Martinez, Randa Melhem, PhD, Randy L Self, Ranjani Prabhakara, Rashmi Rawat, PhD, Raymond T Oji, Rebecca K Olin, Rebecca Rodriguez, Regina Gibson Melton, Regina T Brown, Reyes Candau Chacon, PhD, Richard A Abate, Richard B Mcaroy, Richard D Manney, Richard H Penta, Richard Heath Coats, Richard K Vogel, Richard L Friedman, Richard L Licari, Richard T Riggie, Richard W Thornton, Robert Aksamit, PhD, Robert C Coleman, Robert D Tollefsen, Robert J Maffei, Robert J Martin, Robert Jennings, Robert L Lewis, Jr, Robert L Stevenson, Robert O'brian, Robert W Fisher, Robin Levis, PhD, Rochelle L Cross, Roger F Zabinski, Roman T Drews, PhD, Rory K Geyer, Rose Ashley, Rose Xu, Roy R Rinc, Rupa Pradhan, Russell J Glapion, Russell K Riley, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Sam Pepe, Samantha J Bradley, Samir C Gala, Samuel K Mathew, Samuel Mathew, Samuel W Labinjo, Sandra P White, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Santos E Camara, Sarah E Mcmullen, Sarah Forney, Scott C Lute, Scott R Nichols, PhD, Scott T Ballard, Sean M Tessicini, Sean R Marcsisin, Sena G Dissmeyer, Seneca D Toms, Sergey S Akimov, Seth A Mailhot, Shafiq S Ahadi, Sharmila Shrestha, Sharon K Thoma, PharmD, Shawn R Gould, Sherry M Nisson, Sheryl A Kochman, Shirley J Berryman, Shirley S Wen, Shuang Tang, Sidney B Priesmeyer, Simone E Pitts, Slater K Bartlett, Sneha S Patel, Stacey S Degarmo, Stephen C King, Stephen C Smith, Stephen D Brown, Stephen D Eich, Stephen J Mottola, Stephen R Souza, Steven A Gonzales, Steven B Hertz, Steven C Madzo, Steven E Kane, Steven Fong, MS, PhD, Steven J Thurber, Steven M Ferrara, Steven M Weinman, Steven P Donald, Stewart, Stuart W Russell, Sukyoung Sohn, Sunita Pandey, Susan A Zullo, PhD, Susan F Laska, MS, Susan Kirshner, Susan M Jackson, Susan P Bruederle, Susan Yu, Susanna E Ford, Susanne M Richardson, MS RAC, Suwaskie S Smith, Suzanne M Healy, Svetlana A Shestopal, Swati Verma, Sylvia A Craven, Taichun Qin, PhD, Teddy Tom, Temar Q Williams, Teresita C Mercado, Terri L Dodds, Terry C Kimball, Thai D Truong, Theresa L Stewart, Thomas A Peter, Thomas Cote, Thomas J Arista, Thomas R Withers, Thomas W Nerney, Thuy T Nguyen, LCDR, Timothy K Lee, PhD, Timothy M Glod, Tina M Pawlowski, Tina S Roecklein, Tod J Merkel, Toyin B Oladimeji, Tracy J Washington, Tracy K Li, Travis S Bradley, Troy C Quander, Troy R Petrillo, Unnee Ranjan, Uttaniti Limchumroon (Tom), Veronica L Call, Vesna V Stanoyevitch, Victor J Gangi, Victoria M Daddeo, Vijaya L Simhadri, Vioela J Caze, Viviana Matta, Viviana R Ramirez, Vlada Matusovsky, Walter L Fava, Walter N Lange, Wanda E Pagan, PhD, Wayne E Seifert, Wella Wang, Wendy G Tan, PhD, William A Warnick, William H Linkroum, Xiaokuang Lai, PhD, Xiomara Copeland, Yanming An, PhD, Yonggang Wang, PhD, Youmin Wang, Yuan Chia Kuo, Yumi J Hiramine, Zachary A Bogorad, Zakaria I Ganiyu, Ze Peng, Zhong Li, PhD, Zhongren Wu

LCDR Debra Emerson's Documents

Publish Date Document Type Title
December, 2019 FDA 483 Rentschler Biopharma Inc. - Form 483, 2019-12-13
December, 2009 FDA 483 SGS Life Sciences Services - Form 483, 2009-12-10
January, 2016 EIR Charles River Laboratories, Inc. DBA Charles River, Endosafe - EIR, 2016-01-13
July, 2003 FDA 483 Oraceutical LLC - Form 483, 2003-07-08
May, 2018 EIR AbbVie Bioresearch Center - EIR, 2018-05-24
February, 2018 FDA 483 OKC Allergy Supplies, Inc. - Form 483, 2018-02-23
August, 2008 FDA 483 Ameridose, LLC - Form 483, 2008-08-06
December, 2015 EIR Barr Laboratories Inc. - EIR, 2015-12-18
June, 2014 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2014-06-10
March, 2021 EIR bluebird bio, Inc. - EIR, 2021-03-09
July, 2010 FDA 483 Lonza Biologics, Inc. - Form 483, 2010-07-23
February, 2019 EIR Cangene BioPharma, LLC - EIR, 2019-02-16
November, 2021 EIR Catalent Maryland, Inc. - EIR, 2021-11-17
July, 2017 FDA 483 Response CSL Behring L.L.C. - Form 483R, 2017-08-07
May, 2018 FDA 483 AbbVie Bioresearch Center - Form 483, 2018-05-24
March, 2017 FDA 483 MassBiologics - Form 483, 2017-03-09
March, 2013 FDA 483 Village Fertility Pharmacy, Inc. - Form 483, 2013-03-13
April, 2021 FDA 483 Response Emergent Manufacturing Operations Baltimore LLC - Form 483R, 2021-04-30
December, 2009 FDA 483 SGS Canada Inc - Form 483, 2009-12-10
July, 2003 FDA 483 Response Oraceutical LLC - Form 483R, 2003-09-29
December, 2017 EIR Emergent Biodefense Operations Lansing LLC - EIR, 2017-12-21
December, 2017 FDA 483 Emergent Biodefense Operations Lansing LLC - Form 483, 2017-12-21
January, 2014 EIR Shire Human Genetic Therapies, Inc. - EIR, 2014-01-30
February, 2019 FDA 483 Response Cangene BioPharma, LLC - Form 483R, 2019-03-08
June, 2012 FDA 483 Siegfried Hameln GmbH - Form 483, 2012-06-14
December, 2011 FDA 483 Citra Labs, LLC - Form 483, 2011-12-09
July, 2010 EIR Ameridose, LLC - EIR, 2010-07-08
March, 2021 FDA 483 Response bluebird bio, Inc. - Form 483R, 2021-03-17
February, 2018 FDA 483 Response OKC Allergy Supplies, Inc. - Form 483R, 2018-03-16
January, 2013 FDA 483 Central Admixture Pharmacy Services, Inc. - Form 483, 2013-01-29
April, 2021 FDA 483 Emergent Manufacturing Operations Baltimore LLC - Form 483, 2021-04-20
September, 2013 FDA 483 Lonza Biologics, Inc. - Form 483, 2013-09-30
March, 2014 EIR Fareva Amboise - EIR, 2014-03-18
March, 2021 FDA 483 bluebird bio, Inc. - Form 483, 2021-03-09
July, 2016 FDA 483 Sanofi Winthrop Industrie - Form 483, 2016-07-19
June, 2010 FDA 483 Genzyme Corporation - Form 483, 2010-06-02
November, 2019 FDA 483 MassBiologics - Form 483, 2019-11-19
November, 2021 FDA 483 Response Catalent Maryland, Inc. - Form 483R, 2021-11-17
December, 2009 FDA 483 ANI Pharmaceuticals Canada, Inc. - Form 483, 2009-12-18
May, 2014 FDA 483 Protein Sciences Corporation - Form 483, 2014-05-22
October, 2014 FDA 483 GlaxoSmithKline Biologicals SA - Form 483, 2014-10-02
September, 2013 EIR Lonza Biologics, Inc. - EIR, 2013-09-30
July, 2014 EIR Emergent BioSolutions Canada Inc - EIR, 2014-07-18
January, 2012 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2012-01-06
February, 2014 EIR Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - EIR, 2014-02-28
May, 2015 EIR Corixa Corporation - EIR, 2015-05-13
November, 2018 EIR Associates of Cape Cod, Inc. - EIR, 2018-11-08
October, 2012 FDA 483 New England Compounding Pharmacy, Inc. - Form 483, 2012-10-26
April, 2012 FDA 483 Peptido, chemische und pharmazeutische Rohstoffgesellschaft mit beschränkter Haftung - Form 483, 2012-04-06
June, 2018 EIR Cangene BioPharma, LLC - EIR, 2018-06-13
June, 2012 FDA 483 Armstrong Pharmaceuticals, Inc. - Form 483, 2012-06-14
April, 2003 EIR Vermed, Inc. - EIR, 2003-04-21
September, 2021 FDA 483 CSL Behring L.L.C. - Form 483, 2021-09-24
December, 2007 FDA 483 Research Packaging, Inc. - Form 483, 2007-12-19
October, 2016 FDA 483 Octapharma AB - Form 483, 2016-10-03
December, 2014 FDA 483 Jubilant HollisterStier LLC - Form 483, 2014-12-02
December, 2006 FDA 483 Critical Therapeutics Inc - Form 483, 2006-12-15
August, 2011 EIR AMAG Pharmaceuticals, Inc. - EIR, 2011-08-03
July, 2017 FDA 483 CSL Behring L.L.C. - Form 483, 2017-07-19
November, 2021 FDA 483 Catalent Maryland, Inc. - Form 483, 2021-11-17
May, 2009 FDA 483 Bio-Concept Laboratories, Inc - Form 483, 2009-05-14
March, 2022 FDA 483 CSL Behring GmbH - Form 483, 2022-03-04
October, 2008 FDA 483 Resilience US, Inc. - Form 483, 2008-10-10
December, 2019 EIR Rentschler Biopharma Inc. - EIR, 2019-12-13
October, 2006 FDA 483 PLZ Corp - Form 483, 2006-10-04
November, 2012 FDA 483 Alaunus Pharmaceutical, LLC - Form 483, 2012-11-16
June, 2014 EIR Merck Sharp & Dohme LLC - EIR, 2014-06-10
June, 2013 FDA 483 AstraZeneca Nijmegen B.V. - Form 483, 2013-06-21
November, 2007 FDA 483 Braintree Laboratories, Inc. - Form 483, 2007-11-20
April, 2022 FDA 483 LFB USA, Inc. - Form 483, 2022-04-08
August, 2006 FDA 483 Pharmalucence Inc. - Form 483, 2006-08-02
August, 2012 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2012-08-31
August, 2008 FDA 483 Response Ameridose, LLC - Form 483R, 2008-08-22
January, 2016 FDA 483 Charles River Laboratories, Inc. DBA Charles River, Endosafe - Form 483, 2016-01-13
May, 2018 FDA 483 Response AbbVie Bioresearch Center - Form 483R, 2018-06-07
February, 2019 FDA 483 Cangene BioPharma, LLC - Form 483, 2019-02-16
November, 2019 FDA 483 Response MassBiologics - Form 483R, 2019-11-19
August, 2017 FDA 483 Response Novartis Pharma Stein AG - Form 483R, 2017-09-14
June, 2012 EIR Siegfried Hameln GmbH - EIR, 2012-06-14
February, 2020 FDA 483 SANOFI WINTHROP INDUSTRIE - Form 483, 2020-02-18
July, 2014 FDA 483 Emergent BioSolutions Canada Inc - Form 483, 2014-07-18
July, 2011 FDA 483 Dyax Corp. - Form 483, 2011-07-08
September, 2006 EIR EMD Serono, Inc. - EIR, 2006-09-07
June, 2018 FDA 483 Cangene BioPharma, LLC - Form 483, 2018-06-13
March, 2014 FDA 483 Response Fareva Amboise - Form 483R, 2014-04-08
September, 2015 FDA 483 Bavarian Nordic Berna GmbH - Form 483, 2015-09-11
November, 2009 FDA 483 Resilience US, Inc. - Form 483, 2009-11-13
May, 2019 EIR Charles River Laboratories, Inc. DBA Charles River, Endosafe - EIR, 2019-05-17
April, 2010 FDA 483 Lonza Biologics, Inc. - Form 483, 2010-04-21
July, 2003 EIR Oraceutical LLC - EIR, 2003-07-08
October, 2021 FDA 483 Lonza Biologics, Inc. - Form 483, 2021-10-22
January, 2012 EIR Shire Human Genetic Therapies, Inc. - EIR, 2012-01-06
March, 2012 FDA 483 Sun Pharmaceutical Industries, Inc. - Form 483, 2012-03-13
December, 2015 FDA 483 Barr Laboratories Inc. - Form 483, 2015-12-18
April, 2017 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2017-04-28
September, 2019 FDA 483 Biovex, Inc. - Form 483, 2019-09-27
September, 2021 FDA 483 Response CSL Behring L.L.C. - Form 483R, 2021-10-15
September, 2010 EIR Biogen, Inc. - EIR, 2010-09-08
February, 2014 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2014-02-28
June, 2015 FDA 483 GlaxoSmithKline Vaccines Srl - Form 483, 2015-06-26
July, 2021 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2021-07-23
July, 2010 EIR Ameridose, LLC - EIR, 2010-07-15
August, 2011 FDA 483 AMAG Pharmaceuticals, Inc. - Form 483, 2011-08-03
September, 2019 FDA 483 GenTrac Inc. - Form 483, 2019-09-12
November, 2015 FDA 483 Novo Nordisk A/S - Form 483, 2015-11-06
October, 2008 FDA 483 Response Resilience US, Inc. - Form 483R, 2008-10-31
May, 2011 FDA 483 Lonza Biologics, Inc. - Form 483, 2011-05-06
November, 2018 FDA 483 Associates of Cape Cod, Inc. - Form 483, 2018-11-08
April, 2008 FDA 483 The Gillette Company - Form 483, 2008-04-09
June, 2018 FDA 483 Response Cangene BioPharma, LLC - Form 483R, 2018-07-13
May, 2019 FDA 483 Charles River Laboratories, Inc. DBA Charles River, Endosafe - Form 483, 2019-05-17
April, 2022 FDA 483 Response LFB USA, Inc. - Form 483R, 2022-04-08
August, 2008 EIR Ameridose, LLC - EIR, 2008-08-06
April, 2003 FDA 483 Vermed, Inc. - Form 483, 2003-04-21
December, 2017 FDA 483 Response Emergent Biodefense Operations Lansing LLC - Form 483R, 2018-01-16
May, 2022 EIR Emergent BioSolutions Canada Inc - EIR, 2022-07-07
May, 2022 FDA 483 Emergent BioSolutions Canada Inc - Form 483, 2022-05-10

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