FDA Investigator Calvin B Koerner
Calvin B Koerner has conducted inspections on 9 sites in 4 countries as of 18 Jul 2005. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
9
Last Inspection Date:
18 Jul 2005
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
Puerto Rico,
United States of America,
Canada,
Germany
FDA Investigators that have inspected at least one site in common with Calvin B Koerner:
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,
Caryn M Everly,
Caryn M Mcnab,
Cathleen A Carr Sharpe,
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 H Pluznik, PhD,
Dr. Mark J Seaton, PhD,
Dr. Ralph M Bernstein, PhD,
Dr. Zhihao Qiu (Peter), PhD,
Dustin R Abaonza,
Dyana K Stone,
Edmund F Mrak, Jr,
Eliezar Ramos,
Emily Shacter,
Eric L Dong, BS,
Erika V Butler,
Frederick L Fricke,
Gerald Feldman,
Gerald M Feldman, PhD,
Gilbert T Salud,
Gregory A Berg,
Hai Lient Phung,
Helen B Ricalde,
Henry K Lau,
Ibad U Khan,
Ivis L Negron,
Jacek Cieslak, PhD,
James R Evans,
Janet D Blount,
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 A Lopez,
Jose Acruz Gonzalez,
José E Meléndez,
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 Phommachanh,
Kim Lthomas Cruse,
Kirsten L Vadheim, PhD,
Lakisha M Williams,
Lance Mde 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,
Mark R Mcclain,
Marsha W Major,
Maxwell Van Tassell, PhD,
Megan A Haggerty,
Michael A Charles,
Michael Shanks, MS,
Michael T Cyrus,
Michelle Rfrazier Jessen, PhD,
Michelle Yclark Stuart,
Mihaly S Ligmond,
Milva E Melendez Perales,
Min Shanmabel Liu,
Mra Davism,
Myriam M Sosa,
Nancy G Schmidt,
Nayan J Patel,
Nealie C Newberger,
Nicholas L Hunt,
Nicholas Obiri, PhD,
Nikolay Spiridonov,
Noreen Muñiz,
Nydia E Colon,
Omotunde O Osunsanmi,
Patricia F Hughes, PhD,
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 Jennings,
Rodney D Combs,
Rose 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 L Beaucage,
Shannon B Ruelle,
Sheilyn H Huang,
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,
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,
Zhong Li, PhD,
Ziyang Su, PhD
Calvin B Koerner's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| August, 2004 | EIR | Biogen Idec, Inc. - EIR, 2004-11-05 |
| August, 2004 | EIR | Biogen MA Inc. - EIR, 2004-08-27 |
| May, 2005 | EIR | Amgen Manufacturing Limited LLC - EIR, 2005-05-20 |
| January, 2003 | FDA 483 | Shire Biologics, Div. of Shire Biochem Inc. - Form 483, 2003-01-23 |
| May, 2005 | FDA 483 | Amgen Manufacturing Limited LLC - Form 483, 2005-05-20 |
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