FDA Investigator John A Iwen

John A Iwen has inspections in 6 countries as of 16 Nov 2023. John A Iwen has collaborated with a combinined 6192 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
667
Last Inspection Date:
16 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, India, Canada, Belgium, Norway
Co-Investigator(s):
Adam J Taylor, Adree N Anderson, Adrienne Morgan, Alexander M Kay, Alia Legaux, Alicia M Frees, Allen F Hall, Alysia C Alger, Amanda B Athey, Amanda E Lewin, PhD, Amanda S Zorn, Amy W Yan Mai, Andrace Lde Yampert, Andrea A Branche, Andrew A Hoopes, Anita R Michael, Anna L Tucker, Anthony E Keller, RPh, Aqualia L Nelson, Arindam Dasgupta, PhD, Arthur Z Liang, Babatunde Ojo, Barbara D Wright, Barbara G Peoples, Barbara Janine Breithaupt, Barbara L Rogolsky, Bonnie E Pierson, Bonnie L Menzel, Brandi E Williams, Brent M Dehaan, Brent T Hall, Brentley S Collins, Brett R Havranek, Brian D Nicholson, Brian R Cronenwett, Brittany D Terhar, Bruce E Taylor, Bryan Baker, Camilla S Smith, Candace S Tucker, Carl A Huffman, III, Carl J Montgomery, Carmen Y Fisher, Catherine Whiteside, PhD, CDR Rochelle B Young, RPh, MSA, Chad E Schmear, Charles N Dupont, Christina L Bigham, Christopher D Snyder, Christopher J Smith, Claire M Minden, Clifford F Long, Clotia Cabbey Mensah, Cody D Rickman, Cody J Alley, Collins M Mason, Conner N Mann, Connie L Hannon Rabel, Courtney N Long, Craig T Rybus, Dale A Nyberg, Dan G Eisenbrey, Dana D Carter, SR DDS, Dana M Klimavicz, Daniel L Aisen, Daniel Sagardia Vazquez, Daphne A Videau, Darla J Christopher, Darlene L Krieger, Darrah, David J Eide, David K Glasgow, David L Miser, Dawn C Olenjack, Deborah S Hammond, Debra Boyd Seale, Debra L Boyd Seale, Decarlos A Gomez, Denise L Burosh, Deniza Karacic, Dennis R Hudson, Dewayne E Whitlock, Diana K Krepel, Diana M Guidry, Diane Hall, Dianna D Wardlow Dotter, Dina K West, Dina Kloost, Dolores E Price, Donald W Jehn, Donna D Gallien, MPH, Dr. Gopa Biswas, PhD, Dr. Jason R Caballero, Dustin K Hampton, Edward A Brunt, Edward D Harris, Edward E Lockwood (EEL), Edward J Janik, Elizabeth L Holmes, Ellen C Weisensel, Elmina E Akwo, Eric C Fox, Eric C Nielsen, Eric M Mueller, PharmD, Eric M Padgett, Eric T Huebler, Erika V Butler, Esther A Ofori, Farhana Khan, Francis A Guidry, Fred K Kelly, Gajendiran Mahadevan, PhD, Garrad R Poole, Gene D Arcy, Gene R Gunn, George Ivan Wey, Gerald L Vandevorde, Gerald Mierle, Gloria J Baca, MS, Gregory S Larson, Hasan A Irier, PhD, Heath W Cartwright, Henry E Sanchez, Herbert Arden, Herbert E Arden, Howard A Burmester, Humera T Khan, Ingrid Y Johnson, Ismael Olvera, IV, James D Planchon, James I Giefer, James L Finn, James M Kewley, James P Duggan, Janae D Price, Janesa A Licorish, Janet B Abt, Janete A Eaker, Janete A Oliveira, Janete F Guardia, Jason F Chancey, Jeanne J Chiu, Jeanne J Thai, Jeanne M Morris, Jeffery A Hangartner, Jeffery L Sumter, Jeffrey B Moody, Jennifer A Jones, Jennifer C Adams, Jennifer C Johnson, Jesse P Romenesko, Jessica E Hensley, Jessica L Walters Moell, Jill J Tillman, Jin Young Park, PhD, John Iwen, John J Welsh, PhD, John L Stevens, Johnson, Johnsont, Jonathan R Campos, Joselin P Baray Alvarado, Joseph L Despins, PhD, Joseph R Lambert, Juanelma H Palmer, Judy Ellen Ciaraldi, Julian C Hanson, Julie N Vosilus, Ka L Wong, Kaarin M Slotte, Kamara Mo, Kara L Roden, Karen C Daugherty, Karen Daugherty, Karen M Labounty, Karen M Montgomery (KMM), Karlton T Watson, Katherine M Taylor, Kathleen B Swat, Kathleen J Close, Kathleen M Bradley, Kathryn A Krentz, Kellia N Hicks, Kellie L Thommes, RN, Kellie L Westerbuhr, Kelly D Moore, Kelly D Sheppard, Kelsey A Hustedt, Kenneth R Merritt, Kevin A Beavers, Kimberly A Dux, Kip J Hanks, Kirtida Patel, Kristi B Panzer, Kristi Mhampton Thurston, Lakecha N Lewis, Lauren A Crivellone, Lauren E Skokan, Lauren E Swantko, Lauren M Lilly, PhD, Laurie A Haxel, Laverne Puckett, LCDR Audra J Lenhart, LCDR Matthew J Morrison, Leeterry Moore, Lequita M Mayhew, Li Hongpaul Yeh, PhD, Linda K Cline, Linda R Kuchenthal, Linda S Leja, Linhart, Lisa L Flores, Lisa L Gilliam, Lisa M Puttonen, Lisa R Jennings, Lloyd D Payne, Lori A Gioia, Lorie S Hannappel, Lucas B Leake, Lyndsey G Smith, M Aabel I, Maira P Brading, Makini Cobourne Duval, PhD, Marcia A Worley, Margaret L Bolte, Margaret Torres Vazquez, Marion D Wimberly, Jr, Mary Ann Ruff, Mary E Baker Brown, Mary Ewilkerson Brinsko, Mathur, Meisha Waters, Melinda L Rice, Melissa D Kalik, Melissa J Holz, Merelynn Rhoten, Michael A Feingold, Michael D Robinson, Michael I Gorman, Michael S Kopf, Michele L Obert, Michele M Falchek, Michele Perry Williams, Mohsen Rajabi Abhari, FDA, Monique M Brooks, Nancy G Schmidt, Naseem S Jouhari, Nathan R Moon, Neali H Lucas, Nicola M Fenty Stewart, Nicole J Conklin, Nimmy Mathews, Pamela L Vega, Patricia A Mcilroy, Patrick L Wisor, Paul M Chefor, Paula J Bretz, Peng Zhou, Peter Kessler, PhD, Philip J Boston, Phung Thien Nguyen, Ponzoj, Randy D Baxter, Rashonda N Rucker, Raymond W Brullo, Rebecca T Davis, Reggie D Cope, Richard L Rutherford, Richard T Riggie, Rita K Kabaso, Robert C Steyert, Robert J Ham, Robert J Nesselhauf, Robert M Tillman, Robert S Sweeton, Roberta W Cunningham, Rocco C Black, Rodney D Combs, Roger D Gawne, Roger J Adams, Ronda R Loyd Jones, Russell K Riley, Ryan S Martin, Samuel K Gibbons, Jr, Sandra A Hughes, Sandra Sejdinovic, Sarah A Palmer, Scott A Jepson, Scott B Laufenberg, Scott T Ballard, Shafiq S Ahadi, Shanna R Ausfahl, Shanna R Haden, Sharon M Harold, Shaun M Olson, Shawn B Johnson, Shelley H Beausoleil, Shelley H Roberts, Shirley J Berryman, Sondra L Phillips, Sripal R Mada, PhD, State Agency, Stephanie Mangigian, MS/OSH, RN, Steven D Kehoe, Steven E Porter, Jr, Steven P Allen, Stroman, Sunitha K Rajaram, PhD, Susan D Yuscius, Susan M Miller, Susan M North, Susanna E Ford, Analyst, Tamara J Umscheid, Tamera H Hunt, Tania Y Hall, Tara A Marshall, Tara C Alcazar, Tara K Carmody, Tawny L Colling, Ted L Anderson, Teresa S Johnson, Terry L Jensen, Theresa C Klaman, Theressa B Smith, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Timothy P Lafave, Todd M Stankewicz, Torrey M Ward, Traci M Armand, Tracy J Washington, Uruaku A Obasi, Valeria A Moore, Veronica Fuentes, MS, Vickie J Kanion, Vien Q Le, Virgilio F Pacio, CSO, Walsworth, Warren J Lopicka, Wayne D Mcgrath, Wayne W Grundstrom, William C Corley, William F Lagud, Jr, William J Foust, William Suminski, Xikui Chen (nmi), PhD, Yaw O Osei, Young M Choi, PhD, Young M Yoon, Yvonne C Wilkes

John A Iwen's Documents

Publish Date Document Type Title
April, 2000 EIR Knapp, Dr Howard R - EIR, 2000-04-17
August, 2010 FDA 483 Dental Prosthetic Services Inc - Form 483, 2010-08-18
May, 2005 EIR University of Iowa Pharmaceuticals - EIR, 2005-05-25
May, 2001 EIR Airgas Usa, LLC - EIR, 2001-05-07
March, 2004 EIR University of Iowa Pharmaceuticals - EIR, 2004-03-10
November, 2003 FDA 483 Raining Rose, Inc. - Form 483, 2003-11-04
December, 2013 FDA 483 University of Iowa Pharmaceuticals - Form 483, 2013-12-13
July, 2003 EIR University of Iowa Pharmaceuticals - EIR, 2003-07-17
April, 2001 FDA 483 Response Cambrex Charles City, Inc - Form 483R, 2001-04-26
February, 2022 EIR CSL Plasma - EIR, 2022-02-16
February, 2005 EIR University of Iowa Bone Healing Lab - EIR, 2005-02-04
July, 2003 FDA 483 University of Iowa Pharmaceuticals - Form 483, 2003-07-17
December, 2004 FDA 483 TJN Mfg Inc - Form 483, 2004-12-14
February, 2002 EIR Airgas Usa, LLC - EIR, 2002-02-05
May, 2005 FDA 483 Response University of Iowa Pharmaceuticals - Form 483R, 2005-06-06
March, 2000 EIR University of Iowa Pharmaceuticals - EIR, 2000-03-20
July, 2001 EIR University of Iowa Pharmaceuticals - EIR, 2001-07-05
June, 2000 EIR University of Iowa Pharmaceuticals - EIR, 2000-06-14
April, 2000 FDA 483 Knapp, Dr Howard R - Form 483, 2000-04-17
March, 2001 EIR THE PROCTER & GAMBLE MANUFACTURING COMPANY - EIR, 2001-03-29
February, 2001 EIR Strauss, Dr John S - EIR, 2001-02-19
May, 2001 FDA 483 Airgas Usa, LLC - Form 483, 2001-05-07
May, 2005 FDA 483 University of Iowa Pharmaceuticals - Form 483, 2005-05-25
January, 2002 EIR Airgas-North Central Inc - EIR, 2002-01-29
April, 2001 FDA 483 Cambrex Charles City, Inc - Form 483, 2001-04-13
April, 2009 FDA 483 University of Iowa Pharmaceuticals - Form 483, 2009-04-21
December, 2004 FDA 483 Hansen Ophthalmic Development Lab Inc - Form 483, 2004-12-27

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.


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