FDA Investigator Dawn L Wydner

Dawn L Wydner has conducted inspections on 153 sites in 9 countries as of 16 Aug 2011. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
153
Last Inspection Date:
16 Aug 2011
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Bulgaria, United Kingdom of Great Britain and Northern Ireland, Denmark, Hong Kong, Romania, China, Italy, Thailand
FDA Investigators that have inspected at least one site in common with Dawn L Wydner:
Addam S Reynolds, Adetutu M Gidado, Aditi S Thakur, Albert M Brindle, Alberto A Viciedo, Allen Lou, Althea A Williams, Amy Franklin, Amy Kim, 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 R Kwilas, Annemarie B Randow, Annemarie Bodnar, Arindam Dasgupta, PhD, Atul J Agrawal, Barbara J Maulfair, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Burnell M Henry, Byungja 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, Deborah B Nixon, Denise M Visco, Investigator, Denise M Visu, Dennis E Guilfoyle, PhD, Dhaval H Patel, Diane B Radice, Dolores Harper, Doreen P Canetti, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Abhijit Raha, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Edward O'shaughnessy, Emest F Bizjak, Emily A Walters, Emmanuel Jramos Maldonado, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Esteban Beltran, Eufemia G Gonzalez, Frank J Marciniak, Frederick F Razzaghi, Gene D Arcy, George Pyramides, Gianine E Delade, Gobiga Vanniyasingam, Guerlain Ulysse, Gwyn G Dickinson, Haley H Seymour, Helen B Ricalde, Helen Verdel, Hitesh R Patel, Hyojong Kwon, PhD, Iqra Iftikhar, J David Doleski, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James R Birkenstamm, Janet A Rajan, Janet Donnelly, Jean Blackston 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 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, Kinh Q Mac, Kip J Hanks, Kish Bolden, 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, Lenahan Lenahan, Peter R, Li Li, Liatte Kreuger, PharmD, Linda Thai, Lisa Harlan, Lisa Mathew, Loretta Nemchik, 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 Yau, PhD, 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, Michael F Skelly, PhD, Michael R Klapal, Michael Serrano, Michael Skelly, Michelle A Marsh, Mohsen Rajabi Abhari, FDA, Monica L Gutierrez, 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 M Tampal, PhD, Nimmy Mathews, Nina Yang, Omotunde O Osunsanmi, Patricia F Hughes, PhD, 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 Ashley, Russell J Glapion, Ruth A Williams, Saleem A Akhtar, Sam Chan, Samir C Gala, Samuel Mindaye, Sandra Kershaw, Sarah Adella Fave, Sarah Forney, Schultz, Sherri J Liu, Sheryl A Kochman, Shirley S Wen, Simone E Pitts, Sinai I Davis, Stephanie T Durso, Stephen J Koniers, Stephen J Mottola, Susan M Halsted, Susan T 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, Victoria Spivak, Wayne E Seifert, Wayne J Meyer, William J Muszynski, William R Chang, William W Dotts, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Xingfang Li, MD, Yan Wang, Yvesna C Blaise

Dawn L Wydner's Documents

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

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