FDA Investigator Karen E D'orazio

Karen E D'orazio has inspections in 7 countries as of 03 Nov 2023. Karen E D'orazio has collaborated with a combinined 6632 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
143
Last Inspection Date:
03 Nov 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
Country:
United States of America, China, Germany, United Kingdom of Great Britain and Northern Ireland, Canada, Ireland, Italy
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Alexandra A Carrico, Allen Lou, Amatul H Marium, Amy L Singer, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia M Shields, Andrew J Molesky, Angela E Glenn, Anissa M Vargas, Anita R Michael, Ankur C Patel, Ann Marie Montemurro, Ann Marie Schofield, Annemarie B Randow, Annemarie Bodnar, Anthony J Donato, Anthony M Criscuolo, Jr, Antoinette L Ravelli, Atul J Agrawal, Azza Talaat, Barbara J Maulfair, Barbara J Wilimczyk, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara L Rellahan, PhD, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Brenda S Zimmer, PhD, Brett R Havranek, Bruce H Mccullough, Byungja E Marciante, Cara M Minelli, Carl A Perez, Carla A Norris, Carla J Lundi, Cary Greene, CDR Ileana Barreto Pettit, Charisse K Green, Charles J Chacko, Cheryl A Grandinetti, Christina N Maurino, Christine M Cerenzio, Christopher R Czajka, Clotia Cabbey Mensah, Colin E Tack, Cory Greene, Craig W Swanson, Cynthia Jim, CSO, Daniel J Grabicki, Daniel J Min, David A Oluwo, David H Smith, David J Hafner, David L Pearce, Dawn L Wydner, Deborah B Goffman, Deborah B Nixon, Deborah J Parris, Debra I Love, Debra L Pagano, Denise M Visco, Investigator, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Devon Jenkins, Deyaa Shaheen, Dhaval H Patel, Dinesh Kumar, Doan T Nguyen, PharmD, Donald L Lech, Donna Mwilliams Hill, Dorothy J Denes, Douglas C Kovace, Douglas C Kovacs, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Ralph M Bernstein, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Edmund F Mrak, Jr, Eileen A Liu, Elizabeth Ll Edwards, Emest F Bizjak, Emily A Walters, Emmanuel J Ramos, Emmanuel Jramos Maldonado, Eric J Cunningham, Eric L Dong, BS, Eric Rothschild, Eric S Weilage, Erika V Butler, Erin D Mccaffery, Esteban Beltran, Felix Maldonado, Frank J Marciniak, Frank Wackes, Frederick Razzaghi, Gale E Ryan, Gene D Arcy, George J Flynn, George M Ibrahim, George Pyramides, Gianine E Delade, Gianine E Tompkins, Ginger M Sykes, Gobiga Vanniyasingam, Guerlain Ulysse, Haitao Li, Hector A Carrero, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Jacqueline Mdiaz Albertini, James C Maclaughlin, James I Giefer, James L Dunnie, Jr, James M Mason, Janet A Rajan, Janet L Bowen, Jason Kwong, Jason M Sluzynski, Javier E Santos, Jawaid Hamid, Jay B Shah, Jean Blackston Hill, Jean Blackstone Hill, Jean M Kelahan, Jeffery B Medwid, PhD, Jeffrey A Sommers, Jeffrey J Ebersole, Jeffrey J, Ebersole, Jessica L Pressley, Jessica M Monteiro, Jessica S Estriplet, Jill M Sooter, Jill Mielziner, Joan A Loreng, Joanne E King, Jogy George, John P Mistler, Jonathan G Matrisciano, Jonee J Mearns, Jose Acruz Gonzalez, Jose M Cayuela, Jose R Hernandez, Joseph Duca, Joseph F Mcginnis, RPh, Josh Renzon Ramilo, Joy Rkozlowski Klena, Juanita P Versace, Judith A Paterson, Julie D Bringger, Junho Pak, Justine Tomasso, Karen D'crazio, Karishma G Gopaul, Kassa Ayalew, MD, Katie L Korchinski, Katie L Penno, Kazi Rafiquzzaman, Keith M Reilley, Keith M Reilly, Kelli F Dobilas, Kelli F Regenye, Kelli Regente, Kellia N Hicks, Kelly Doremus, Kenneth M Gordon, Kerry A Kurdilla, Kevin A Gonzales, Kevin A Gonzalez, Kevin D Kallander, Kevin Obrien, Kevin P Foley, Kim Lthomas Cruse, King, Kinh Q Mac, Ko U Min, Krishnaiah Yellela, Kristen D Evans, Kristina L Conroy, Kristy A Zielny, Krystal O Ogunremi, Krystyna M Kitson, Laishan L Lam, Larry Johnson, Larry K Austin, Lata C Mathew, PhD, Latorie S Jones, Laurel A Beer, Lauren L Vajo, Laurie A Haxel, Lawrence Harmon, Jr, Lawrence R Johnson, LCDR Michael H Tollon, Leticia S Jones, Li Li, Liatte Kreuger, PharmD, Linda Thai, Lisa B Hall, Lisa Harlan, Lisa Mathew, Loretta Nemchik, Luis A Dasta, Luis M Burgos Medero, Lydia Irosas Marty, Malik S Qaiser, Manhar R Patel, Maotang Xhou, Maotang Zhou, PhD, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcus F Yambot, Marea K Harmon, Margaret E Walsh, Margaret M Sands, Maria Estrella, Maria Manzoni, PhD, Marjorie D Schultz, Mary E Farbman, PhD, Matthew A Spataro, Matthew B Casale, Matthew R Dionne, Mayar M Mussa, Melba T Rivera, Melba Trivera Clavell, Melissa A Freeman, Melissa A Zuppe, Melissa B Libby, Melissa D Ray, Melissa T Roy, Merril E Racke, Meyer J Slobotsky, Michael E Maselli, Michael P Sheehan, Michael R Goga, Michael R Klapal, Michael Serrano, Michele Gottshall, Michele L Obert, Miguel G Manzano, Monika Borkowska, Mra Davism, Mra Mcculloughj, Nadeem I Chaudhry, Nancy F Scheraga, Nancy G Schmidt, Nancy L Rolli, Nancy M Espinal, Nancy Roll, Nancy Sheraga, Nerizza B Guerin, Nicholas A Violand, Nicholas E Squillante, Niketa Patel, Nikki S Ramirez, Nina Yang, Niraj Mehta, Nutan Mytle, Pankaj H Amin, Parul M Patel, Patsy J Domingo, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Pete Amin (Pankaj), Peter R Lenahan, Prabhu P Raju, Rabin N Ghoshal, Ralph H Vocque, Raquel Gonzalez Rivera, Raymond T Oji, Regina T Brown, Remache, Richard D Manney, Richard E Needham, Richard H Penta, Richard W Thornton, Richard W Thorntton, Robert D Tollefsen, Robert G Ruff, Robert J Maffei, Robert Sharpnack, Robert W Jennings, Robin P Mathew, Rochelle K Kimmel, Rochelle L Cross, Rodney T Allnutt, Rodrigo Vilchez, Roger F Zabinski, Rosario D'costa, Rose Ljean Mary, Russell J Glapion, Russell K Riley, Sachinkumar V Patel, Saleem A Akhtar, Samir C Gala, Sandra A Boyd, Sandra Kershaw, Sarah Adella Fave, Sarah E Mcmullen, Sarah E Rhoades, Sarah Forney, Schultz, Scott J Lewis, Sena G Dissmeyer, Shahla Parvizi, Sharon K Thoma, PharmD, Sherri J Liu, Sherry G Bous, Shirley H Isbill, Shirley S Wen, Sidney B Priesmeyer, Simone E Pitts, Simone Pins, Sinai Davis, Sinai I Davis, Srinivas R Chennamaneni, PhD, State Agency, Stephanie A Slater, MS, Stephanie T Durso, Stephen D Brown, Stephen J Koniers, Stephen J Mottola, Stephen R Souza, Stephenie M Ortiz, Steven A Gonzales, Steven B Hertz, Steven D Kehoe, Steven M Weinman, Steven P Donald, Steven Wienman, Susan F Laska, MS, Susan M Halsted, Susan M Jackson, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Tamil Arasu, PhD, Tania E Garcia, Tania E Vizcaino, Tara G Bizjak, Tara R Bizjak, Tara R Gooen, Thomas E Friel, Thomas J Arista, Thomas M Herbst, Tonia F Bernard, Toniette Williams, Toyin B Oladimeji, Tracey L Harris, Truong Xuan Nguyen (Andy), Tyanna N Hadley, Tynna N Hadley, Unnee Ranjan, Valerie C Reed, Valerie Reed, Victoria A Wagoner, Victoria Spivak, Wai H Lam, Wayne J Meyer, Wayne T Smith, Wei Wang, PhD, Willy A Orantes, Xiaohan Cai, PhD, Xiaokuang Lai, PhD, Xiuju Lu, Yoriann Mcabrera Bartolomei, Yumi J Hiramine, Yvesna C Blaise, Yvins Dezan, Zakaria I Ganiyu, Zhijin Chen

Karen E D'orazio's Documents

Publish Date Document Type Title
April, 2002 FDA 483 Pfizer Inc. - Form 483, 2002-04-03
September, 2010 FDA 483 Genzyme Corporation - Form 483, 2010-09-02
February, 2004 FDA 483 Response Novus Fine Chemicals - Form 483R, 2004-03-08
January, 2003 EIR Actavis Elizabeth LLC - EIR, 2003-01-15
September, 2006 EIR Consumer Product Testing Company, Inc - EIR, 2006-09-29
September, 2009 FDA 483 Tri-Med Laboratories Inc - Form 483, 2009-09-25
April, 2003 EIR Tokyo Kaneku International Inc. - EIR, 2003-04-17
July, 2003 EIR Actavis Elizabeth LLC - EIR, 2003-07-15
April, 2010 FDA 483 Sun Pharmaceutical Industries, Inc. - Form 483, 2010-04-28
October, 2003 FDA 483 Halo Pharmaceutical Inc - Form 483, 2003-10-24
April, 2009 EIR LTS Lohmann Therapy Systems Corp. - EIR, 2009-04-27
September, 2005 FDA 483 Response Aphena Pharma Solutions - Form 483R, 2005-09-09
November, 2009 FDA 483 Glatt Air Techniques, Inc. - Form 483, 2009-11-06
August, 2009 FDA 483 BASF Corporation - Form 483, 2009-08-18
November, 2007 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2007-11-29
June, 2003 EIR Carecam International, Inc. - EIR, 2003-06-09
January, 2007 FDA 483 Response Amneal Pharmaceuticals, LLC - Form 483R, 2007-01-24
August, 2003 FDA 483 Response Actavis Totowa LLC - Form 483R, 2003-09-19
May, 2006 EIR McNeil PPC Inc. - EIR, 2006-05-24
September, 2010 FDA 483 IDT Biologika GmbH - Form 483, 2010-09-14
June, 2003 FDA 483 Response Carecam International, Inc. - Form 483R, 2003-07-01
July, 2003 EIR DSM Nutritional Products, LLC - EIR, 2003-07-30
July, 2002 EIR Pliva, Inc. - EIR, 2002-07-26
January, 2007 EIR Amneal Pharmaceuticals, LLC - EIR, 2007-01-24
January, 2010 EIR Integrated Analytical Laboratories, LLC. - EIR, 2010-01-25
September, 2003 EIR Ingenus Pharmaceuticals NJ, LLC - EIR, 2003-09-19
July, 2003 EIR Case Laboratories, Inc. - EIR, 2003-07-09
August, 2004 EIR Pharmachem Laboratories, LLC. - EIR, 2004-08-11
June, 2004 EIR DSM Nutritional Products, LLC - EIR, 2004-06-18
December, 2003 FDA 483 Response McNeil PPC Inc. - Form 483R, 2003-12-30
June, 2010 FDA 483 Tri-Med Laboratories Inc - Form 483, 2010-06-21
February, 2004 EIR Novus Fine Chemicals - EIR, 2004-02-18
April, 2003 FDA 483 Tokyo Kaneku International Inc. - Form 483, 2003-04-17
May, 2008 FDA 483 The P.F. Laboratories Inc. - Form 483, 2008-05-16
November, 2007 EIR LTS Lohmann Therapy Systems Corp. - EIR, 2007-11-29
November, 2008 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2008-11-10
February, 2005 EIR Ivax Pharmaceuticals Inc - EIR, 2005-02-22
February, 2005 FDA 483 Ivax Pharmaceuticals Inc - Form 483, 2005-02-22
October, 2003 EIR Jamol Laboratories, Inc. - EIR, 2003-10-08
October, 2006 FDA 483 Imperial Drug And Spice Company - Form 483, 2006-10-20
December, 2003 FDA 483 McNeil PPC Inc. - Form 483, 2003-12-17
May, 2008 EIR The P.F. Laboratories Inc. - EIR, 2008-05-16
March, 2003 FDA 483 The P.F. Laboratories Inc. - Form 483, 2003-03-27
November, 2006 FDA 483 McNeil PPC Inc. - Form 483, 2006-11-20
October, 2004 EIR MPL Laboratories - EIR, 2004-10-22
July, 2009 FDA 483 Omega Packaging Corporation - Form 483, 2009-07-14
November, 2010 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2010-11-17
September, 2006 FDA 483 Response Consumer Product Testing Company, Inc - Form 483R, 2006-10-13
May, 2004 EIR Aphena Pharma Solutions - New Jersey, LLC - EIR, 2004-05-10
January, 2008 EIR Cardinal Health 414, LLC - EIR, 2008-01-15
May, 2004 FDA 483 Aphena Pharma Solutions - New Jersey, LLC - Form 483, 2004-05-10
March, 2008 FDA 483 Tri-Med Laboratories Inc - Form 483, 2008-03-19
August, 2006 FDA 483 Englewood Lab, Inc. - Form 483, 2006-08-28
January, 2007 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2007-01-24
August, 2013 FDA 483 Johnson & Johnson Consumer, Inc - Form 483, 2013-08-30
January, 2003 FDA 483 Actavis Elizabeth LLC - Form 483, 2003-01-15
May, 2008 FDA 483 Response The P.F. Laboratories Inc. - Form 483R, 2008-06-30
December, 2005 EIR Ivax Pharmaceuticals Inc - EIR, 2005-12-21
September, 2003 FDA 483 Ingenus Pharmaceuticals NJ, LLC - Form 483, 2003-09-19
September, 2006 FDA 483 Consumer Product Testing Company, Inc - Form 483, 2006-09-29
April, 2009 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2009-04-27
June, 2011 FDA 483 Cardinal Health 414, LLC - Form 483, 2011-06-16
April, 2002 EIR Hoffmann La Roche Inc - EIR, 2002-04-30
June, 2009 FDA 483 Cardinal Health 414, LLC - Form 483, 2009-06-24
August, 2006 FDA 483 Intergel Pharmaceuticals Inc - Form 483, 2006-08-07
August, 2013 FDA 483 Novel Laboratories, Inc. - Form 483, 2013-09-11
April, 2007 EIR Barr Laboratories Inc - EIR, 2007-04-12
March, 2010 EIR Intertek USA, Inc. - EIR, 2010-03-03
October, 2003 FDA 483 Response Halo Pharmaceutical Inc - Form 483R, 2003-11-05
May, 2004 FDA 483 Response Aphena Pharma Solutions - New Jersey, LLC - Form 483R, 2004-05-21
March, 2006 FDA 483 Ingenus Pharmaceuticals NJ, LLC - Form 483, 2006-03-22
January, 2008 FDA 483 Cardinal Health 414, LLC - Form 483, 2008-01-15
May, 2007 FDA 483 Aphena Pharma Solutions - New Jersey, LLC - Form 483, 2007-05-09
February, 2004 FDA 483 Novus Fine Chemicals - Form 483, 2004-02-18
December, 2003 EIR McNeil PPC Inc. - EIR, 2003-12-17
September, 2005 EIR Aphena Pharma Solutions - EIR, 2005-09-09
June, 2003 FDA 483 Carecam International, Inc. - Form 483, 2003-06-06
March, 2013 FDA 483 Drugs Are Us, Inc., dba Hopewell Pharmacy - Form 483, 2013-03-21
October, 2003 EIR Halo Pharmaceutical Inc - EIR, 2003-10-24
October, 2004 FDA 483 MPL Laboratories - Form 483, 2004-10-22
April, 2007 FDA 483 Barr Laboratories Inc - Form 483, 2007-04-12
January, 2010 FDA 483 Integrated Analytical Laboratories, LLC. - Form 483, 2010-01-25
June, 2005 FDA 483 Response Actavis Totowa LLC - Form 483R, 2006-08-29
August, 2003 FDA 483 Actavis Totowa LLC - Form 483, 2003-08-21
September, 2002 EIR Barr Laboratories, Inc. - EIR, 2002-09-06
April, 2002 FDA 483 Response Pfizer Inc. - Form 483R, 2002-04-22
May, 2007 EIR Aphena Pharma Solutions - New Jersey, LLC - EIR, 2007-05-09
June, 2005 EIR Actavis Totowa LLC - EIR, 2005-06-07
April, 2002 EIR Pfizer Inc. - EIR, 2002-04-03
December, 2005 FDA 483 Ivax Pharmaceuticals Inc - Form 483, 2005-12-21
January, 2010 FDA 483 SGS North America Inc. - Form 483, 2010-01-14
August, 2003 EIR Actavis Totowa LLC - EIR, 2003-08-21
November, 2006 EIR McNeil PPC Inc. - EIR, 2006-11-20
August, 2008 FDA 483 Genzyme Corporation - Form 483, 2008-08-22

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