FDA Investigator James I Giefer

James I Giefer has inspections in 10 countries as of 15 Sep 2023. James I Giefer has collaborated with a combinined 5434 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
93
Last Inspection Date:
15 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United Kingdom of Great Britain and Northern Ireland, United States of America, Germany, Sweden, Norway, Switzerland, Ireland, Finland, Italy, Austria
Co-Investigator(s):
Adree N Anderson, Alan L Brend, Alan P Kurtzberg, Alberto A Viciedo, Albinus M D Sa, Alex M Viehmann, Almaris N Alonso, Amir A Abdalla, Amy E Devine, Ana Paulap Sandee, Andrew A Hoopes, Anita Narula, PhD, Anthony R Bucks, Ashley A Mutawakkil, Barbara Janine Breithaupt, Barbara L Rogolsky, Bei Y He, Bijoy Panicker, Blondell W Johnson, Bo Chi, PhD, Brent M Dehaan, Brent T Hall, Brett R Havranek, Brian D Nicholson, Bridgette M Mattern, Brittany D Terhar, Bruce H Mccullough, Bryan S Roddy, Candace S Tucker, Candido Torres, Carl A Huffman, III, Carla J Lundi, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Ceisha C Ukatu, Chad W Rice, Charles M Edwards, Charles O'brein, Chih Jung Hsu, PhD, Christine A Harman, PhD, Christine W Twohy, Christopher T Middendorf, Christopher T Peters, Cody D Rickman, Concannon, Conner Mann, Conner N Mann, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia M Goudeau, Dale A Nyberg, Damaris Y Hernandez, Danial S Hutchison, David A Place, David G Eng, David J Eide, David K Glasgow, David L Miser, Dawn C Olenjack, Deborah J Parris, Debra I Love, Dennis Cantellops Paite, Dennis R Downer, Derrionna M Epps, Devaughn Edwards, Dina K West, Don H Bark, PhD, Donald L Myers, Donna Mwilliams Hill, Douglas A Campbell, Douglas M Monroe, Dov Pluznik, PhD, Dr. Robert C Horan, MD, Dustin K Hampton, Edecia A Richards, Edmund F Mrak, Jr, Edward E Lockwood (EEL), Elmina E Mboh, Emilio O Escobar, Eric C Nielsen, Eric M Mueller, PharmD, Eric M Padgett, Erie C Nielsen, Erika V Butler, Farhana Khan, Felix Maldonado, Frank Wackes, Gayle S Lawson, Georgia A Layloff, Gerald B Seaborn, Jr, Gloria J Champagne, Gwyn G Dickinson, Hala L Selby, Hector A Carrero, Helen Y Saccone, Hongjian Ding, Iram R Hassan, PhD, Jacek Cieslak, PhD, Jacob G Lutz, Jacqueline Mdiaz Albertine, Jacqueline Mdiaz Albertini, James D Bridges, James D Planchon, James L Dunnie, Jr, Janet B Abt, Janis R Armedoriz, Javier O Vega, Jazmine N Still, Jeffery L Sumter, Jeffrey A Sommers, Jennifer D Hollstrom, Jennifer M Gogley, Jill J Tillman, Jmaes I Giefer, Joanne E King, Joey V Quitania, John A Iwen, John A Marchin, John C Mcmichael, John D White, John L Stevens, Johnsont, Jonathan R Campos, Jorge L Gonzalez, Jose Acruz Gonzalez, Jose Alopez Rubet, Joseph R Lambert, Joseph R Strelnik, Juandria Williams, Julie N Vosilus, Julie V Bailey, Junho Pak, Justin A Boyd, Kalavati Suvarna, PhD, Kara L Cooper, Kara L Roden, Karen C Daugherty, Karen E D'orazio, Karen M Montgomery (KMM), Karthik B Iyer, Katherine Szestypalow, Kathleen B Swat, Kathleen M Bradley, Kellia N Hicks, Kelly A Lynch, Kelly K Nachtigal, Ken L Bowers, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kshitij A Patkar, Latorie S Jones, Lawrence J Stringer, LCDR Chad N Thompson, Linda F Murphy, Lisa L Flores, Lisa L Gilliam, Logan T Williams, Lori B Wikstrom, Lorie S Hannappel, Lucas B Leake, Mai X Huynh, Margaret A Smithers, Margaret M Annes, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marion D Wimberly, Jr, Mary K Concannon, Matthew B Casale, Matthew H Hunt, Matthew M Schuckmann, Matthew Ondeck, Matthew R Sleeter, Matthew Schuckman, Meisha R Sampson, Meisha Waters, Melanie M Walker, Melinda L Rice, Meyer J Slobotsky, Michael A Charles, Michael C Zubelewicz, Michael D Porter, Michael R Goga, Michael Shanks, MS, Michele L Obert, Michele Perry Williams, Michelle D Haamid, Miguel A Martinez, Mihaly S Ligmond, Minh D Phan, Miranda D Mcdonald, Monica E Murie, Monica M Mcclure, Mra Davism, Mra Mcculloughj, Mra Munizn, Nancy G Schmidt, Neal L Adams, Nicholas A Violand, Nicholas L Paulin, Noreen Muniz, Omotunde O Osunsanmi, Pamela L Vega, Pamela N Agaba, Parul M Patel, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul L Bellamy, Paula A Trost, Philip J Boston, Phillip M Pontikos, Ralph A Erickson, Ralph H Vocque, Randy D Moore, Rebecca Rodriguez, Regina T Brown, Renee S Blosser, Reyes Candau Chacon, PhD, Richard L Rutherford, Rick L Friedman, Rita K Kabaso, Robert D Tollefsen, Robert J Ham, Robert M Tillman, Robin K Reel, Rodney G Raiford, Roger F Zabinski, Rohit B Kolhatkar, Rose M Ashley, Roy R Rinc, Saleem A Akhtar, Salvatore N Randazzo, Samantha J Bradley, Sandra A Boyd, Sandra A Hughes, Sangeeta M Khurana, PhD, Santos E Camara, Sarah E Rhoades, Scott A Golladay, Scott R Nichols, PhD, Shafiq S Ahadi, Shanna R Haden, Sharon K Thoma, PharmD, Sherry G Bous, Shirley J Berryman, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Soyinka S Eneng, Sri Ramakrishnaiah Yellela, Srinivas R Chennamaneni, PhD, State Agency, Stephen D Eich, Steven C Madzo, Steven D Kehoe, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susanna E Ford, Analyst, Susant Hadman, Tamara J Umscheid, Tammy L Smith, Tara L Breckenridge, Tara L Greene, Tara L King, Terri L Dodds, Thomas E Friel, Thomas J Arista, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tonya R Johnson, Torrance J Slayton, Torrey M Ward, Vaishali J Patel, Valshall Patel, Veronica Fuentes, MS, Veronica L Call, Victoria A Wagoner, Victoria P Quadrini, Vikas Moolchandani, Walden H Lee, Walsworth, Walsworth Walsworth, Warren J Lopicka, Wayne D Mcgrath, Wayne E Seifert, William C Corley, William Hallett, PhD, William J Leonard, Xianghong Jing (Emily), PhD, Xiaohan Cai, PhD, Yasamin Ameri, Yiyue Zhang (nmi), PhD, Zachary A Bogorad, Zedong Dong, Zhong Li, PhD, Zi Qiang Gu

James I Giefer's Documents

Publish Date Document Type Title
October, 2000 FDA 483 Laboratories Serono S.A. - Form 483, 2000-10-13
March, 2001 EIR Hospira, Inc. - EIR, 2001-03-29
March, 2003 EIR Alcami Carolinas Corporation - EIR, 2003-03-12
July, 2001 FDA 483 Eurofins EAG Materials Science, LLC - Form 483, 2001-07-02
October, 2001 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2001-09-27
November, 2002 FDA 483 Response GE Healthcare Ltd - Form 483R, 2002-11-01
July, 2001 FDA 483 Sanofi-Aventis US LLC - Form 483, 2001-07-26
March, 2001 FDA 483 Hospira, Inc. - Form 483, 2001-03-29
November, 2002 FDA 483 Pfizer Inc - Form 483, 2002-11-20
June, 2001 EIR Reliable Biopharmaceutical LLC - EIR, 2001-06-22
May, 2000 FDA 483 Bioniche, Teo - Form 483, 2000-05-05
May, 2003 FDA 483 Alcami Carolinas Corporation - Form 483, 2003-05-08
March, 2000 EIR Monsanto Co - EIR, 2000-03-10
February, 2000 FDA 483 SpecGx LLC - Form 483, 2000-02-16
September, 2002 EIR Hospira, Inc. - EIR, 2002-09-12
August, 2003 FDA 483 Sigma-Aldrich Manufacturing LLC - Form 483, 2003-08-01
February, 2002 EIR Takeda Ireland Limited - EIR, 2002-02-05
April, 2002 FDA 483 Sandoz GmbH - Form 483, 2002-04-30
June, 2003 FDA 483 Norbrook Laboratories, Ltd - Form 483, 2003-06-17
April, 2000 FDA 483 Curium US LLC - Form 483, 2000-04-14
February, 2002 EIR SpecGx LLC - EIR, 2002-02-15
April, 2001 FDA 483 Pharmacia AB Plant Bolanderna - Form 483, 2001-04-20
April, 2000 EIR Curium US LLC - EIR, 2000-04-14
September, 2002 FDA 483 Hospira, Inc. - Form 483, 2002-09-12
October, 2000 FDA 483 Norbrook Laboratories, Ltd - Form 483, 2000-10-19
April, 2002 EIR Sandoz GmbH - EIR, 2002-04-30
August, 2002 EIR Meridian Medical Technologies, LLC - EIR, 2002-08-07
February, 2003 FDA 483 S&B Pharma LLC DBA Alkem Laboratories - Form 483, 2003-02-05
May, 2003 FDA 483 Response Alcami Carolinas Corporation - Form 483R, 2003-05-15
January, 2002 EIR Curium US LLC - EIR, 2002-01-25
November, 2002 FDA 483 Response Cambrex Karlskoga AB - Form 483R, 2002-11-07
June, 2003 EIR Norbrook Laboratories Limited - EIR, 2003-06-17
January, 2001 EIR SpecGx LLC - EIR, 2001-01-19
June, 2000 FDA 483 Curium US LLC - Form 483, 2000-06-27
November, 2002 EIR Cambrex Karlskoga AB - EIR, 2005-10-27
October, 2004 FDA 483 Curium US LLC - Form 483, 2004-10-20
July, 2001 EIR R.D. Laboratories, Inc. - EIR, 2001-07-09
May, 2000 EIR Mylan Teoranta - EIR, 2000-05-05
January, 2002 FDA 483 Curium US LLC - Form 483, 2002-01-25
August, 2002 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2002-08-07
June, 2002 FDA 483 Meridian Medical Technologies Inc., A Pfizer Company - Form 483, 2002-06-25
September, 2002 EIR Virbac Corporation - EIR, 2002-09-20
April, 2002 FDA 483 Response Sandoz GmbH - Form 483R, 2002-05-13
October, 2000 EIR Bayer Oy - EIR, 2000-10-27
November, 2001 EIR Curium US LLC - EIR, 2001-11-06
September, 2003 FDA 483 Response Curium US LLC - Form 483R, 2003-09-26
September, 2002 FDA 483 Virbac Corporation - Form 483, 2002-09-20
March, 2001 FDA 483 Response Hospira, Inc. - Form 483R, 2001-07-19
March, 2004 EIR Cambrex Charles City, Inc - EIR, 2004-03-18
June, 2001 FDA 483 Reliable Biopharmaceutical LLC - Form 483, 2001-06-22
October, 2000 EIR Norbrook Laboratories Limited - EIR, 2000-10-19
September, 2003 FDA 483 Curium US LLC - Form 483, 2003-09-17
May, 2002 FDA 483 Argenta Dundee Limited - Form 483, 2002-05-09
October, 2003 EIR R.D. Laboratories, Inc. - EIR, 2003-10-01
October, 2003 FDA 483 Aventis Behring Gmbh - Form 483, 2003-10-31
November, 2002 EIR GE Healthcare Ltd - EIR, 2002-12-11
July, 2004 FDA 483 Tyco Healthcare/Mallinckrodt - Form 483, 2004-07-20
October, 2003 EIR Aventis Behring Gmbh - EIR, 2003-10-31
July, 2001 EIR Sanofi-Aventis US LLC - EIR, 2001-07-26
May, 2000 FDA 483 Response Mylan Teoranta - Form 483R, 2000-05-23
October, 2003 EIR SpecGx LLC - EIR, 2003-10-16
April, 2003 EIR Alcami Carolinas Corporation - EIR, 2003-04-03
April, 2002 EIR Alcami Carolinas Corporation - EIR, 2002-04-10
April, 2001 EIR Recipharm Uppsala AB - EIR, 2001-04-20
July, 2004 EIR SpecGx LLC - EIR, 2004-07-23
January, 2002 FDA 483 Response Curium US LLC - Form 483R, 2002-02-01
May, 2002 EIR Argenta Dundee Limited - EIR, 2002-05-09
October, 2000 FDA 483 Response Bayer Oy - Form 483R, 2000-11-03
May, 2003 EIR Alcami Carolinas Corporation - EIR, 2003-05-08
February, 2000 EIR SpecGx LLC - EIR, 2000-02-16
April, 2001 FDA 483 Response Recipharm Uppsala AB - Form 483R, 2001-06-28

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