FDA Investigator Calvin B Koerner

Calvin B Koerner has inspections in 3 countries as of 11 Aug 2023. Calvin B Koerner has collaborated with a combinined 4108 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
9
Last Inspection Date:
11 Aug 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
100000411
Country:
United States of America, Canada, Germany
Co-Investigator(s):
Adaliz Santaliz Cruz, Adam R Cooke, Alan A Rivera, Alan P Kurtzberg, Amanda L Fyles, Amir Alavi, Amy C Jordan, Amy N Chen, Andrea A Branche, Andrea George, PhD, Andrew S Limson, Angel K Sandhu, Anh M Lac, Anita Narula, PhD, Ann Marie Montemurro, Arlene M Badillo, Arthur S Williams, Jr, Ashley N Queen, PhD, Barbara J Wilcox, PhD, Bichsa T Tran, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Bryan A Galvez, Burnell M Henry, Carl Lee, Carla J Lundi, Carole L Jones, Carr Sharpe, Caryn M Everly, Caryn M Mcnab, CDR Thomas R Berry, PPh, Christopher Downey, PhD, Christopher R Czajka, Colleen Thomas, PhD, Comyar Shoghi, Cynthia Jim, CSO, Daniel J Roberts, Daryl A Dewoskin, Deborah M Trout, Dennis Cantellops Paite, Devaughn Edwards, Dien N Nguyen, Donald C Obenhuber, PhD, Dov Pluznik, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dustin R Abaonza, Dyana K Stone, Edmund F Mrak, Jr, Eliezar Ramos, Emily Shacter, Eric L Dong, BS, Erika V Butler, Frederick Fricke, Frederick L Fricke, Gerald Feldman, Gerald M Feldman, PhD, Gilbert T Salud, Gregory A Berg, Hai Lien T Phung, Helen B Ricalde, Henry K Lau, Henry X Lau, Ibad U Khan, Ivis Lnegron Torres, Jacek Cieslak, PhD, James R Evans, Janet Blount, Janet D Bart, Jason F Chancey, Jeanne Fringer, PhD, Jeffery A Johnson, Jeffrey M Watson, Jennifer Lalama, Jennifer M Gogley, Jerri Baker, Jie He, Joan T Briones, Joe X Phillips, Joey V Quitania, John A Gonzalez, Jorge L Lajara, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose R Lopez, Jose Velez, Joseph F Owens, Joseph Kutze, PhD, Joseph P Iser, MD, Joseph X Phillips, Joshua S Hunt, Julie D Bringger, Justine Tomasso, Karen A Briggs, Katherine E Jacobitz, Kelvin Cheung, Kevin P Foley, Kham Phommachang, Kham Phommachanh, Kim Lthomas Cruse, Kirsten L Vadheim, PhD, Lakisha M Williams, Lance M De Souza, MBA, Laura I Salazar, PhD, Laurie P Norwood, LCDR Jennifer H Rhyu, Lei Zhang, PhD, Leiyun Boone, PhD, Libia M Lugo, Linda F Murphy, Linh Tu, Lois K Gross, LT Rafael Gonzalez, Mabel M Lee, Maida Henesian (NMI), Marco S Esteves, Marcus F Yambot, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marian E Ramirez, Marie K Kinkade, Marion Michaelis, Mariza M Jafary, Mariza M Jalary, Mark R Mcclain, Marsha W Major, Maxwell Van Tassell, PhD, Megan A Haggerty, Michael A Charles, Michael Shanks, MS, Michelle Rfrazier Jessen, PhD, Michelle Y Clark Stuart, Mihaly S Ligmond, Milva E Melendez, Milva Emelendez Perales, Min Shanma Liu, Mra Davism, Myriam M Sosa, Nancy G Schmidt, Nayan J Patel, Nayan Patel, Nealie C Newberger, Nicholas Obiri, PhD, Nikolay Spiridonov, Noreen Muniz, Noreen Muñiz, Nydia E Colon, Omotunde O Osunsanmi, Pabhu P Raju, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul E Stein, Paul Z Balcer, Paula A Trost, Peter E Baker, Peter Kessler, PhD, Prabhu P Raju, Priscilla M Pastrana, Ralph Jerndal, Ramesh Potla, PhD, Ramon A Hernandez, Raymond T Oji, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Rebecca T Davis, Reyes Candau Chacon, PhD, Richard K Vogel, Richard Ledwidge (nmi), PhD, Riley C Myers, PhD, Robert C Coleman, Robert D Tollefsen, Robert Darius, Robert W Jennings, Rodney D Combs, Rose M Ashley, Samuel K Gibbons, Jr, Sandra S Saniga, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Scott N Lim, Sean R Marcsisin, Seneca D Toms, Serge Beaucage, Shannon B Ruelle, Shelley H Beausoleil, Sherri J Jackson, Sidney B Priesmeyer, Sparky L Bartee, Stacey S Degarmo, Stephanie A Slater, MS, Stephen C Smith, Stephen D Brown, Steven C Madzo, Steven Fong, MS, PhD, Stuart W Russell, Susan F Laska, MS, Susan M Jackson, Tamara M Casselman, Terri L Dodds, Thea C Grome, Thomas J Arista, Thuy T Nguyen, LCDR, Timothy C Grome, Timothy Wadkin, PhD, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Viviana Matta, Walden H Lee, Walden Lee, Wayne E Seifert, Wendy G Tan, PhD, William Hallett, PhD, William V Millar, Yehualashet A Gessesse, Yetao Jin, PhD, Yi Wang, PhD, Yumi J Hiramine, Zachary L Stamm, Zhao Wang, PhD, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Ziyang Su, PhD

Calvin B Koerner's Documents

Publish Date Document Type Title
May, 2005 FDA 483 Amgen Manufacturing Ltd - Form 483, 2005-05-20
August, 2004 EIR Biogen MA Inc. - EIR, 2004-08-27
January, 2003 FDA 483 Shire Biologics, Div. of Shire Biochem Inc. - Form 483, 2003-01-23
May, 2005 EIR Amgen Manufacturing Ltd - EIR, 2005-05-20
August, 2004 EIR Biogen Idec, Inc. - EIR, 2004-11-05

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