FDA Investigator Kristy A Zielny

Kristy A Zielny has conducted inspections on 162 sites in 16 countries as of 23 Sep 2010. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
162
Last Inspection Date:
23 Sep 2010
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Denmark, France, Sweden, Ireland, Italy, Germany, Finland, Japan, Spain, South Africa, United Kingdom of Great Britain and Northern Ireland, China, India, Croatia, Canada
FDA Investigators that have inspected at least one site in common with Kristy A Zielny:
Addam S Reynolds, Adetutu M Gidado, Alan P Kurtzberg, Albert M Brindle, Alberto A Viciedo, Alicia M Mozzachio, Allen Lou, Amy L Singer, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia M Shields, Andrew R Wasko, Ankur C Patel, Ann L Demarco, Ann Marie Montemurro, Anna Lazar, Anna M Brannen, Annemarie B Randow, Annemarie Bodnar, Annet R Rajan, Anthony A Charity, Anthony J Donato, Anthony M Criscuolo, Jr, Antoinette L Ravelli, Ariel Cruz Figueroa, Ashutosh Rao, PhD, Atul J Agrawal, Aurora Miha Trifanov, Azza Talaat, Barbara J Maulfair, Barbara J Rincon, Barbara Jwilimczyk Macri, Bei Yu, Brenda S Zimmer, PhD, Brian L Belz, Brittany D Terhar, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Carla A Norris, Cary Greene, Cassandra L Abellard, CDR Donald Ertel, Charisse K Green, Charles A Snipes, PhD, Charles J Chacko, Charles M Edwards, Charles R Cote, RIC, Charlotte P Chang, Chiang Syin, PhD, Christina N Maurino, Christina P Burkhart, Christine M Cerenzio, Christine W Twohy, Christopher J Adams, Cody D Rickman, Constantin Y Philopoulos, Craig W Swanson, Cynthia F Kleppinger, MD, Cynthia Jim, CSO, Dan Grabicki, Daniel J Grabicki, Daniel L Obrzut, Daniel W Cline, David E Bailey, David H Smith, David M Beltran, Dawn L Wydner, Deborah A Greco, Deborah B Nixon, Debra I Love, Debra J Bennett, Denise M Digiulio, Denise M Visco, Investigator, Dennis Cantellops Paite, Devon Jenkins, Deyaa Shaheen, Dhaval H Patel, Diane Kelley, Djamila Harouaka, Donald C Obenhuber, PhD, Donald L Lech, Donna Ltartaglino Besone, Doreen P Canetti, Doreen P Gubbay, Dorothy J Denes, Dorothy P Kramer, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Edmond J Baratta, Edward O'shaughnessy, Eileen A Liu, Elaine E Gilfillan, Emest F Bizjak, Emily A Walters, Emily J Orban, Emmanuel Jramos Maldonado, Eric Rothschild, Erika V Butler, Erin D Mccaffery, Esteban Beltran, Eufemia G Gonzalez, Francis A Guidry, Frank J Marciniak, Fred Razzaghi, Frederick F Razzaghi, George Pyramides, Gerald B Seaborn, Jr, Gianine E Delade, Gianine E Tompkins, Gobiga Vanniyasingam, Graeme E Price, Guerlain Ulysse, Haitao Li, Hala L Selby, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Hitesh R Patel, Israel Santiago, OCM, Ivis L Negron, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Beaulieu, James C Maclaughlin, James M Mason, James R Birkenstamm, James R Evans, Janet A Rajan, Jason M Sluzynski, Javier O Vega, Jawaid Hamid, Jay B Shah, Jay T Wong, Jean M Kelahan, Jean M Mulinde, MD, Jeffrey J Ebersole, Jeffrey P Raimondi, Jennifer A Bazergui, Jennifer L Custodio, Jennifer Macmillan, Jenny Sung, Jessica M Monteiro, Jessica S Estriplet, Jill M Sooter, Jill Mielziner, Joanne E King, Joanne Heim, Joey V Quitania, Jogy George, John A Gonzalez, Jonathan S Helfgott, Jonee J Mearns, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose R Hernandez, Joseph F Mcginnis, RPh, Josh Renzo N Ramilo, Joshua J Silvestri, Joshua P Wireman, Joy Rkozlowski Klena, Juanita P Versace, Julie D Bringger, Junho Pak, Justin A Boyd, Justine Tomasso, Karen A Spencer, Karen E D'orazio, Karen F Tomaziefski, Karen M Cooper, Karishma G Gopaul, Katherine Szestypalow, Keith M Reilly, Kejun Cheng, Kelli F Dobilas, Kelli F Regenye, Kelli Regente, Kellia N Hicks, Kelly I Anderson, Kelly L Anderson, Kenneth G Klobus, Kerry A Kurdilla, Kevin Obrien, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kinh Q Mac, Krishnaiah Yellela, Kristen E Rescigno, Kristy E Zuroski, Laishan L Lam, Larry Johnson, Larry K Austin, Lata C Mathew, PhD, Laura Fontan, MS, Laurel A Beer, Lauren L Vajo, Laurimer Kuilan Torres, Lawrence R Johnson, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Michael H Tollon, Lcr Jayt Wong, Li Li, Liatte Kreuger, PharmD, Lillian S Wu, Lily Y Koo, Liming Zhang, Linda F Murphy, Linda Thai, Lindsey S Fleischman, Lisa Harlan, Lisa M Bellows, Lisa M Feola, Lisa Mathew, Lloyd D Payne, Loretta Nemchik, Lucas B Leake, Luis A Dasta, Luis Mburgos Medero, Manhar R Patel, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Maria A Bienkowski, Maria A Reed, Maria Estrella, Maria Manzoni, PhD, Marian E Ramirez, Marie B Buen Bigornia, Marjorie D Schultz, Mark R Mcclain, Marvin D Jones, Marybet Lopez Negron, Matt D Suedkamp, Matthew A Spataro, Matthew B Casale, Matthew C Watson, Mayar M Mussa, Meisha R Sampson, Meisha Waters, Melba Trivera Clavell, Melissa B Libby, Melissa T Roy, Meredith L Sheridan, Meyer J Slobotsky, Michael A Charles, Michael Gurbarg, Michael L Casner, Michael R Goga, Michael R Klapal, Michael Serrano, Michele Gottshall, Michele L Obert, Miguel A Martinez Perez, Monica E Caphart, Monica L Gutierrez, Monica M Mcclure, Monika Borkowska, Mra Davism, Mra Greenc, Mra Mcculloughj, Mra Munizn, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nerizza B Dalena, Nerizza B Guerin, Nicholas A Violand, Nicole E Knowlton, Niketa Patel, Nikki S Ramirez, Nina Yang, Omotunde O Osunsanmi, Parul M Patel, Patrick C Klotzbuecher, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Peter R Lenahan, Philip F Istafanos, DMV, MS, Pratik S Upadhyay, DDC, Raymond L Cheung, Regina T Brown, Reyes Candau Chacon, PhD, Richard D Manney, Richard K Vogel, Richard Ledwidge (nmi), PhD, Richard W Thornton, Richmond K Yip, Robert D Tollefsen, Robert M Barbosa, Robert Sharpnack, Robin P Mathew, Rochelle K Kimmel, Rochelle L Cross, Rodrigo Vilchez, Roger F Zabinski, Rosa J Motta, Rose Ljean Mary, Rose Xu, Russell J Glapion, S Lori Brown, PhD MPH, Sachinkumar V Patel, Saleem A Akhtar, Samir C Gala, Sangeeta M Khurana, PhD, Santos E Camara, Sarah Adella Fave, Sarah E Mcmullen, Sarah Forney, Sarah M Meng, Satheesh K Podaralla, Sayyem H Akbar, Scott B Laufenberg, Sean G Casey, Shahla Parvizi, Sharon K Thoma, PharmD, Sherri J Liu, Shirley H Isbill, Shirley S Wen, Sidney B Priesmeyer, Simone E Pitts, Sinai I Davis, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen J Koniers, Stephen J Mottola, Stephenie M Ortiz, Steven D Kehoe, Steven M Weinman, Steven P Donald, Steven S Wahl, Suchan Kim, Sue Lee Chan, Susan F Laska, MS, Susan M Halsted, Susan M Jackson, Susan T Hadman, Susan W Ting, Susanna E Ford, Susanne M Richardson, MS RAC, Tamil Arasu, PhD, Tara G Bizjak, Tara R Gooen, Temar Q Williams, Terri L Dodds, Thai D Truong, Thomas E Friel, Tiffani D Wilson, Tonia F Bernard, Tonya R Johnson, Toyin B Oladimeji, Tressa T Lewis, Tricia S Martinez, Truong Xuan Nguyen (Andy), Tyanna N Hadley, Unnee Ranjan, Valerie C Reed, Victor J Gangi, Victoria Spivak, Vincent F Cafiso, Viviana Matta, Walden H Lee, Wayne J Meyer, William J Muszynski, William R Chang, Willy A Orantes, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Yangmin Ning, Yasmin B Rios, Yumi J Hiramine, Yvesna C Blaise, Yvins Dezan, Zachary L Miller, Zakaria I Ganiyu, Zhaohui Ye, Zhong Li, PhD

Kristy A Zielny's Documents

Publish Date Document Type Title
May, 2002 EIR Contract Coating Inc. - EIR, 2002-05-16
September, 2003 EIR Daiichi Sankyo, Inc. - EIR, 2003-09-23
November, 2003 EIR Sandoz Inc. - EIR, 2003-11-18
September, 2002 EIR Able Laboratories Inc. - EIR, 2002-09-18
December, 2005 EIR OHM LABORATORIES INC. - EIR, 2005-12-20
July, 2003 EIR Par Pharmaceutical Companies, Inc. - EIR, 2003-07-17
December, 2005 FDA 483 OHM LABORATORIES INC. - Form 483, 2005-12-20
July, 2003 FDA 483 Par Pharmaceutical Companies, Inc. - Form 483, 2003-07-17
November, 2001 EIR Intergel - EIR, 2001-11-21
November, 2002 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2002-11-07
March, 2003 FDA 483 Able Laboratories Inc. - Form 483, 2003-03-14
August, 2009 EIR Apotex Inc. - EIR, 2009-08-14
February, 2002 FDA 483 Bayer HealthCare LLC - Form 483, 2002-02-04
August, 2001 EIR Actavis Elizabeth LLC - EIR, 2001-08-17
March, 2004 EIR Merck & Co., Inc. - EIR, 2004-03-09
March, 2007 FDA 483 Alcami Corporation - Form 483, 2007-03-14
July, 2001 FDA 483 Blispak, Inc. - Form 483, 2001-07-12
November, 2002 FDA 483 Response LTS Lohmann Therapy Systems Corp. - Form 483R, 2002-12-09
May, 2001 EIR Fisher Scientific Co., LLC - EIR, 2001-05-25
December, 2002 EIR Able Laboratories Inc. - EIR, 2002-12-26
November, 2002 EIR LTS Lohmann Therapy Systems Corp. - EIR, 2002-11-07
October, 2005 FDA 483 Sun Pharmaceutical Industries Ltd. - Form 483, 2005-10-27
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-01
May, 2008 FDA 483 Actavis Totowa LLC - Form 483, 2008-05-20
February, 2003 EIR Frutarom USA Inc. - EIR, 2003-02-25
March, 2008 FDA 483 Renaissance Lakewood LLC - Form 483, 2008-03-18
July, 2001 EIR Blispak, Inc. - EIR, 2001-07-12
October, 2002 EIR Bristol-Myers Squibb Company - EIR, 2002-10-04
November, 2006 FDA 483 Sonar Products, Inc. - Form 483, 2006-11-09
March, 2001 EIR OHM LABORATORIES INC. - EIR, 2001-03-15
March, 2002 EIR Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics - EIR, 2002-03-12
March, 2004 FDA 483 Merck, Inc. - Form 483, 2004-03-09
September, 2007 FDA 483 Actavis Totowa LLC - Form 483, 2007-09-28
May, 2001 FDA 483 Fisher Scientific Co., LLC - Form 483, 2001-05-25
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-28
December, 2007 FDA 483 Cosette Pharmaceuticals, Inc. - Form 483, 2007-12-20
July, 2001 FDA 483 Response Blispak, Inc. - Form 483R, 2001-07-13
October, 2006 FDA 483 Actavis Totowa LLC - Form 483, 2006-10-11
March, 2006 FDA 483 Unigene Laboratories, Inc. - Form 483, 2006-03-21
October, 2001 FDA 483 FAR Specialty Products, Inc. - Form 483, 2001-10-19
May, 2001 FDA 483 Pharmaceutical Formulations Inc. - Form 483, 2001-05-10
September, 2007 EIR Actavis Totowa LLC - EIR, 2007-09-28
February, 2003 FDA 483 Frutarom USA Inc. - Form 483, 2003-02-25
December, 2005 FDA 483 Response OHM LABORATORIES INC. - Form 483R, 2006-01-16
January, 2008 FDA 483 Somerville Acquisitions Co., Inc. - Form 483, 2008-01-18
March, 2004 FDA 483 Response Merck, Inc. - Form 483R, 2004-04-06
May, 2001 EIR Pharmaceutical Formulations Inc. - EIR, 2001-05-10
September, 2003 EIR Sandoz Inc. - EIR, 2003-09-18
August, 2009 FDA 483 Apotex Inc. - Form 483, 2009-08-14
February, 2002 EIR Aspire Pharmaceuticals Inc. - EIR, 2002-02-15
May, 2003 FDA 483 Response Janssen Pharmaceuticals Inc. - Form 483R, 2003-06-02
August, 2009 FDA 483 Response Apotex Inc. - Form 483R, 2009-09-03
August, 2006 FDA 483 Actavis Totowa LLC - Form 483, 2006-08-10
October, 2003 EIR DERMARITE INDUSTRIES, LLC - EIR, 2003-10-09
September, 2001 EIR Bentley Laboratories, LLC - EIR, 2001-09-20
September, 2002 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2002-09-27
May, 2006 EIR LTS Lohmann Therapy Systems Corp. - EIR, 2006-05-18
May, 2003 EIR Janssen Pharmaceuticals Inc. - EIR, 2003-05-19
April, 2003 EIR Compass Pharma Services, LLC - EIR, 2003-04-10
August, 2006 EIR Actavis Totowa LLC - EIR, 2006-08-10
March, 2001 FDA 483 Response OHM LABORATORIES INC. - Form 483R, 2001-04-02
August, 2004 EIR Able Laboratories Inc. - EIR, 2004-08-04
October, 2001 EIR FAR Specialty Products, Inc. - EIR, 2001-10-19
December, 2001 FDA 483 Response Merck, Inc. - Form 483R, 2002-01-25
May, 2006 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2006-05-18
May, 2003 FDA 483 Janssen Pharmaceuticals Inc. - Form 483, 2003-05-19
February, 2002 FDA 483 Able Laboratories, Inc. - Form 483, 2002-02-11
September, 2002 EIR Merck Sharp & Dohme LLC - EIR, 2002-09-27
October, 2003 EIR Par Pharmaceutical Companies, Inc. - EIR, 2003-10-28
March, 2001 FDA 483 OHM LABORATORIES INC. - Form 483, 2001-03-15
January, 2002 FDA 483 VILS Pharma Coating LLC - Form 483, 2002-01-30
December, 2005 EIR OHM LABORATORIES INC. - EIR, 2005-12-20
February, 2002 FDA 483 Aspire Pharmaceuticals Inc. - Form 483, 2002-02-15
December, 2001 FDA 483 Merck, Inc. - Form 483, 2001-12-19
March, 2003 FDA 483 Response Able Laboratories Inc. - Form 483R, 2003-03-19
December, 2001 EIR Merck, Inc. - EIR, 2001-12-19
October, 2003 FDA 483 DERMARITE INDUSTRIES, LLC - Form 483, 2003-10-09
March, 2003 EIR Able Laboratories Inc. - EIR, 2003-03-14
November, 2004 EIR Astellas Pharma Inc. - EIR, 2004-12-15
September, 2002 FDA 483 Response Merck Sharp & Dohme LLC - Form 483R, 2002-10-11
November, 2004 FDA 483 Response Astellas Pharma Inc. - Form 483R, 2005-01-03
April, 2010 FDA 483 Sanofi Chimie - Form 483, 2010-04-30
March, 2004 EIR Merck, Inc. - EIR, 2004-03-09
May, 2002 EIR Nexeo Solutions, LLC. - EIR, 2002-05-31
May, 2001 FDA 483 Response Pharmaceutical Formulations Inc. - Form 483R, 2001-05-29

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