FDA Investigator Dawn L Wydner

Dawn L Wydner has inspections in 10 countries as of 16 Aug 2023. Dawn L Wydner has collaborated with a combinined 4429 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
153
Last Inspection Date:
16 Aug 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Thailand, Romania, Denmark, China, Bulgaria, Italy, Hong Kong, United Kingdom of Great Britain and Northern Ireland
Co-Investigator(s):
A Williams, Addam S Reynolds, Adetutu M Gidado, Aditi S Thakur, Albert M Brindle, Alberto A Viciedo, Allen Lou, Amy Franklin, Amy L Singer, Amy Lynn Frankshun, PhD, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia I Offordile, Ankur C Patel, Ann Marie Montemurro, Ann Marie Schofield, Anna Kevilag, Anna Kwilas, Annemarie B Randow, Annemarie Bodnar, Arindam Dasgupta, PhD, Atul J Agrawal, Barbara J Maulfair, Barbara J Wilimczyk, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Burnell M Henry, Byungja E Marciante, Byungja E Mercuente, Byungja F Marciante, Byungja H Marciante, Byunja E Marciante, Carol A Perry, Carol A Robles, Cary Greene, Charles Yuanchia Kuo, PhD, Charlotte P Chang, Christian D Lynch (CDL), Christina N Maurino, Christopher J Adams, Creighton T Tuzon, Daniel J Grabicki, Darin S Wiegers, David H Smith, Dawa L Wydner, Dawn L Wyndver, Deborah B Nixon, Denise M Visco, Investigator, Denise M Visu, Dennis E Guilfoyle, PhD, Dhaval H Patel, Diane B Radice, Doreen P Canetti, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Abhijit Raha, PhD, Dr. Sriram Subramaniam, PhD, E Marciante, Edmund F Mrak, Jr, Edward Oshaughnessy, Emest Bizjak, Emest F Bizjak, Emily A Walters, Emmanuel J Ramos, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Esteban Beltran, Eufemia G Gonzalez, Frank J Marci, Frank J Marciniak, Frederick Razzaghi, Gene D Arcy, George Pyramides, Gianine E Delade, Gobiga Vanniyasingam, Guerlain Ulysse, Gwyn G Dickinson, Haley H Seymour, Harperd, Helen B Ricalde, Helen Verdel, Herrmann, Hitesh R Patel, Hyojong Kwon, PhD, J David Doleski, Jacqueline A Shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James R Birkenstamm, Janet A Rajan, Janet Donnelly, Jean Blackston Hill, Jean Blackstone Hill, Jean M Kelahan, Jean M Mulinde, MD, Jennifer A Bazergui, Jennifer L Custodio, Jennifer Macmillan, Jessica M Monteiro, Joan A Loreng, Joanne Pryzbylik, Jonah S Ufferfilge, Jonathan Ho, Jonathan S Helfgott, Jonee J Mearns, Jose M Cayuela, Jose O Hernandez, Jose Ohernandez Guzman, Joseph F Mcginnis, RPh, Joy Rkozlowski Klena, Juanita P Versace, Julie D Bringger, Justine Tomasso, Kara A Scheibner, PhD, Karen E D'orazio, Kathleen M Jordan, Kelli F Dobilas, Kelly I Anderson, Kelly L Anderson, Kimberly L Schultz, Kimberly M Bigler, King, Kinh Q Mac, Kip J Hanks, Ko U Min, Kristen E Rescigno, Kristina L Conroy, Kristy A Zielny, Krystal O Ogunremi, Kwong P Lee, Kyle D Covill, Laishan L Lam, Lauren L Vajo, Lawrence R Johnson, LCDR Debra Emerson, Leiyun Boone, PhD, Li Li, Liatte Kreuger, PharmD, Linda Thai, Lisa Harlan, Lisa Mathew, Loretta Nemchik, Loretta Wemchik, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcia Gelber, Marea K Harmon, Margaret M Sands, Maria Estrella, Marion Michaelis, Mariza M Jafary, Marjorie D Schultz, Marlene G Swider, Martha T Olone, Martin K You, Mary T Carden, Matthew W Kyle, Mayar M Mussa, Meihong Liu, Melissa A Freeman, Melissa B Libby, Melissa T Roy, Melkamu Getie Kebtie, PhD, Meredith L Sheridan, Meyer J Slobotsky, Meyer J Sobotsky, Michael R Klapal, Michael Serrano, Michael Skelly, Michelle A Marsh, Mohsen Rajabi Abhari, FDA, Monica L Gutierrez, Mpris Inspector, Myoshi M Francis, Nailing Zhang, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nerizza B Dalena, Nerizza B Guerin, Nicholas A Violand, Niketa Patel, Nikisha M Bolden, Nilufer Tampal, PhD, Nimmy Mathews, Nina Yang, Omotunde O Osunsanmi, Patricia Fhughes Troost, Paul L Bellamy, Paul Mouris, Paula A Trost, Peter R Lenahan, Prabhu P Raju, Qiao Y Bobo, Raymond L Cheung, Regina T Brown, Remache, Richard D Manney, Richard E Needham, Richard J Muzeni, Robert G Ruff, Rodrigo Vilchez, Rose M Ashley, Russell J Glapion, Ruth A Williams, Saleem A Akhtar, Sam Chan, Samir C Gala, Samuel Mindaye, Sandra Kershaw, Sands, Sarah Adella Fave, Sarah Forney, Schultz, Sherri J Liu, Sheryl A Kochman, Shirley S Wen, Simone E Pitts, Sinai Davis, State Agency, Stephanie T Durso, Stephen J Koniers, Stephen J Mottola, Susan M Halsted, Susant Hadman, Tamil Arasu, PhD, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Teigan M Mule, Teresita C Mercado, Thuy T Nguyen, LCDR, Tressa T Lewis, Tyanna N Hadley, Unnee Ranjan, Valerie C Reed, Valerie Reed, Wayne E Seifert, Wayne J Meyer, William J Muszynski, William R Chang, William W Dotts, Xi Kui, cdzn, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Xingfang Li, MD, Yan Wang, Yvesna C Blaise, Zhihao Qiu (Peter), PhD

Dawn L Wydner's Documents

Publish Date Document Type Title
April, 2007 EIR Hikma Pharmaceuticals USA, Inc. - EIR, 2007-04-02
September, 2006 EIR Columbia Laboratories, Inc - EIR, 2006-09-19
May, 2002 EIR OHM LABORATORIES INC. - EIR, 2002-05-06
May, 2002 EIR Musculoskeletal Transplant Foundation, Inc. - EIR, 2002-05-20
May, 2002 FDA 483 Response Musculoskeletal Transplant Foundation, Inc. - Form 483R, 2002-06-05
March, 2011 FDA 483 Essex Institutional Review Board, Inc - Form 483, 2011-03-21
March, 2009 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2009-03-24
June, 2003 FDA 483 Response Jersey Shore University Med Ctr- IRB - Form 483R, 2003-07-01
June, 2008 FDA 483 Johnson & Johnson Pharmaceutical Research & Development, LLC - Form 483, 2008-06-12
January, 2011 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2011-01-28
June, 2003 FDA 483 Jersey Shore University Med Ctr- IRB - Form 483, 2003-06-30
April, 2003 FDA 483 Response Boghossian, Jack MD - Form 483R, 2003-04-09
December, 2008 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2008-12-22
March, 2009 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2009-03-27
April, 2008 FDA 483 Syneos Health Clinical, Inc. - Form 483, 2008-04-18
November, 2010 FDA 483 LifeCell Corporation - Form 483, 2010-11-12
April, 2003 FDA 483 Response JFK Health IRB - Form 483R, 2003-04-23
April, 2003 EIR JFK Health IRB - EIR, 2003-04-23
March, 2011 FDA 483 Response Essex Institutional Review Board, Inc - Form 483R, 2011-04-11
January, 2008 FDA 483 Vantage Specialty Ingredients, Inc - Form 483, 2008-01-11
August, 2005 FDA 483 Response Shelhigh, Inc. - Form 483R, 2005-08-30
May, 2002 FDA 483 Response OHM LABORATORIES INC. - Form 483R, 2002-05-24
April, 2009 FDA 483 Johnson & Johnson Pharmaceutical Research & Development, LLC - Form 483, 2009-04-14
June, 2011 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2011-06-30
March, 2011 EIR Essex Institutional Review Board, Inc - EIR, 2011-03-21
May, 2002 FDA 483 Musculoskeletal Transplant Foundation, Inc. - Form 483, 2002-05-20
November, 2010 EIR LifeCell Corporation - EIR, 2010-11-12
July, 2009 FDA 483 Syneos Health Clinical, Inc. - Form 483, 2009-07-17
April, 2005 EIR Sanofi-Aventis U.S. LLC - EIR, 2005-04-25
June, 2003 EIR Jersey Shore University Med Ctr- IRB - EIR, 2003-06-30
April, 2011 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2011-04-12
July, 2004 EIR IAL Biolytix - EIR, 2004-07-23
August, 2011 EIR Dr. Reddy'S Laboratories - EIR, 2011-08-19
September, 2009 FDA 483 Xenobiotic Laboratories, Inc. - Form 483, 2009-09-24
April, 2003 EIR NovaDel Pharma Inc. - EIR, 2003-04-03
October, 2002 EIR Osteotech, Inc. - EIR, 2002-10-04
June, 2008 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2008-06-12
March, 2009 FDA 483 Johnson & Johnson Pharmaceutical Research & Development, LLC - Form 483, 2009-03-27
October, 2002 FDA 483 Osteotech, Inc. - Form 483, 2002-10-04
May, 2008 EIR J & J Pharmaceutical Research & Develop - EIR, 2008-05-15
January, 2011 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2011-01-28
March, 2003 EIR Denker, Michael M.D. - EIR, 2003-03-13
November, 2010 FDA 483 Response LifeCell Corporation - Form 483R, 2010-12-01
August, 2005 FDA 483 Shelhigh, Inc. - Form 483, 2005-08-10
April, 2005 FDA 483 Sanofi-Aventis U.S. LLC - Form 483, 2005-04-25
April, 2003 EIR Boghossian, Jack MD - EIR, 2003-04-04
April, 2009 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2009-04-14
May, 2002 FDA 483 OHM LABORATORIES INC. - Form 483, 2002-05-06
July, 2011 EIR Bristol Myers Squibb - EIR, 2011-07-27
March, 2004 EIR Jane L. Rohlf, MD - EIR, 2004-03-02
January, 2005 EIR Ross, Joel, M.D. - EIR, 2005-01-21
February, 2008 FDA 483 Tandem Labs A LabCorp Company - Form 483, 2008-02-14
September, 2002 EIR Musculoskeletal Transplant Foundation, Inc. - EIR, 2002-09-19
April, 2003 FDA 483 Boghossian, Jack MD - Form 483, 2003-04-04

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