FDA Investigator Kristy A Zielny

Kristy A Zielny has inspections in 16 countries as of 27 Oct 2023. Kristy A Zielny has collaborated with a combinined 7041 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
162
Last Inspection Date:
27 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Spain, France, Germany, India, Japan, Italy, Croatia, Sweden, Denmark, Canada, South Africa, Ireland, United Kingdom of Great Britain and Northern Ireland, Finland, China
Co-Investigator(s):
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, 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 J Wilimczyk, 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 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 Oshaughnessy, Eileen A Liu, Elaine E Gilfillan, Emest F Bizjak, Emily A Walters, Emily J Orban, Emmanuel J Ramos, Eric Rothschild, Erika V Butler, Erin D Mccaffery, Ernest F Bizjack, Ernie F Bizkaj, Esteban Beltran, Eufemia G Gonzalez, Ferderick Razzaghi, Francis A Guidry, Frank J Marciniak, Fred Razzaghi, Frederick 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 Lnegron Torres, 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, Jennifer A Bazergui, Jennifer L Custodio, Jennifer Macmillan, Jessica M Monteiro, 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 Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose R Hernandez, Joseph F Mcginnis, RPh, Josh Renzon Ramilo, Joshua J Silvestri, Joshua P Wireman, Jot R Klena, Joy R Kelna, Joy R Kozlowski, 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, Karishma Gopaul, Katherine Szestypalow, Keith M Reilly, Kejun Cheng, Kelli F Dobilas, Kelli F Regeny, Kelli F Regenye, Kelli Regente, Kellia N Hicks, Kelly I Anderson, Kelly L Anderson, Kenneth G Klobus, Kenneth Miller, Kenneth V Miller, Kerry A Kurdilla, Kevin Obrien, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kine Thomas 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, 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, Liattle Krueger, 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 M Burgos Medero, Manhar R Patel, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Margaret Sand, Maria A Bienkowski, Maria A Reed, Maria Estrella, Maria Manzoni, PhD, Marian E Ramirez, Marie Bbuen Bigornia, Marjorie D Schultz, Mark R Mcclain, Marvin D Jones, Marybet Lopez, Marybet Lopez Negron, Matt D Suedkamp, Matthew A Spataro, Matthew B Casale, Matthew C Watson, Matthew Sparato, 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 L Obert, Mielziner, Miguel A Martinez, Monica E Caphart, Monica L Gutierrez, Monica M Mcclure, Monika Borkowska, Morea K Harmen, Mra Davism, Mra Greenc, Mra Mcculloughj, 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, Nyungja E Marciente, 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, 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 Davis, Sinai I Davis, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen J Koniers, Stephen J Mottola, Steven D Kehoe, Steven M Weinman, Steven P Donald, Steven S Wahl, Sue Lee Chan, Susan F Laska, MS, Susan M Halsted, Susan M Jackson, Susan W Ting, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Tamil Arasu, PhD, Tara G Bizjak, Tara R Gooen, Temar Q Williams, Terri L Dodds, 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 Chang, 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
October, 2001 EIR Cyalume Specialty Products - EIR, 2001-10-19
September, 2003 EIR Sandoz Inc. - EIR, 2003-09-18
May, 2001 FDA 483 Fisher Scientific Co., LLC - Form 483, 2001-05-25
March, 2004 FDA 483 Merck, Inc. - Form 483, 2004-03-09
November, 2002 FDA 483 Response LTS Lohmann Therapy Systems Corp. - Form 483R, 2002-12-09
March, 2008 FDA 483 Renaissance Lakewood LLC - Form 483, 2008-03-18
May, 2006 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2006-05-18
August, 2006 EIR Actavis Totowa LLC - EIR, 2006-08-10
April, 2003 EIR Compass Pharma Services, LLC - EIR, 2003-04-10
January, 2002 FDA 483 VILS Pharma Coating LLC - Form 483, 2002-01-30
December, 2005 EIR OHM LABORATORIES INC. - EIR, 2005-12-20
December, 2001 FDA 483 Merck, Inc. - Form 483, 2001-12-19
March, 2001 FDA 483 Response OHM LABORATORIES INC. - Form 483R, 2001-04-02
March, 2003 EIR Able Laboratories Inc. - EIR, 2003-03-14
May, 2006 EIR LTS Lohmann Therapy Systems Corp. - EIR, 2006-05-18
April, 2010 FDA 483 Sanofi Chimie - Form 483, 2010-04-30
March, 2004 EIR Merck, Inc. - EIR, 2004-03-09
May, 2001 FDA 483 Response Pharmaceutical Formulations Inc. - Form 483R, 2001-05-29
September, 2002 FDA 483 Response Merck Sharp & Dohme LLC - Form 483R, 2002-10-11
December, 2007 FDA 483 Cosette Pharmaceuticals, Inc. - Form 483, 2007-12-20
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-28
May, 2001 FDA 483 Pharmaceutical Formulations Inc. - Form 483, 2001-05-10
September, 2007 FDA 483 Actavis Totowa LLC - Form 483, 2007-09-28
February, 2003 EIR Frutarom USA Inc. - EIR, 2003-02-25
July, 2001 FDA 483 Blispak, Inc. - Form 483, 2001-07-12
December, 2001 FDA 483 Response Merck, Inc. - Form 483R, 2002-01-25
November, 2006 FDA 483 Sonar Products, Inc. - Form 483, 2006-11-09
March, 2002 EIR Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics - EIR, 2002-03-12
May, 2008 FDA 483 Actavis Totowa LLC - Form 483, 2008-05-20
September, 2002 EIR Able Laboratories Inc. - EIR, 2002-09-18
November, 2002 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2002-11-07
March, 2001 EIR OHM LABORATORIES INC. - EIR, 2001-03-15
July, 2003 EIR Par Pharmaceutical Companies, Inc. - EIR, 2003-07-17
October, 2002 EIR E.R. Squibb & Sons, L.L.C. - EIR, 2002-10-04
October, 2003 EIR DERMARITE INDUSTRIES, LLC - EIR, 2003-10-09
December, 2005 FDA 483 Response Ohm Laboratories Inc. - Form 483R, 2006-01-16
May, 2003 FDA 483 Response Janssen Pharmaceuticals Inc. - Form 483R, 2003-06-02
March, 2004 EIR Merck & Co., Inc. - EIR, 2004-03-09
May, 2002 EIR Contract Coating Inc. - EIR, 2002-05-16
January, 2008 FDA 483 Somerville Acquisitions Co., Inc. - Form 483, 2008-01-18
August, 2009 EIR Apotex Inc. - EIR, 2009-08-14
August, 2006 FDA 483 Actavis Totowa LLC - Form 483, 2006-08-10
September, 2007 EIR Actavis Totowa LLC - EIR, 2007-09-28
October, 2001 FDA 483 Cyalume Specialty Products - Form 483, 2001-10-19
September, 2002 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2002-09-27
August, 2009 FDA 483 Apotex Inc. - Form 483, 2009-08-14
May, 2001 EIR Pharmaceutical Formulations Inc. - EIR, 2001-05-10
October, 2006 FDA 483 Actavis Totowa LLC - Form 483, 2006-10-11
November, 2004 FDA 483 Response Astellas Pharma Inc. - Form 483R, 2005-01-03
February, 2002 FDA 483 Bayer HealthCare LLC - Form 483, 2002-02-04
July, 2001 EIR Blispak, Inc. - EIR, 2001-07-12
February, 2003 FDA 483 Frutarom USA Inc. - Form 483, 2003-02-25
May, 2001 EIR Fisher Scientific Co., LLC - EIR, 2001-05-25
March, 2004 FDA 483 Response Merck, Inc. - Form 483R, 2004-04-06
December, 2005 FDA 483 Ohm Laboratories Inc. - Form 483, 2005-12-20
August, 2001 EIR Actavis Elizabeth LLC - EIR, 2001-08-17
December, 2002 EIR Able Laboratories Inc. - EIR, 2002-12-26
March, 2007 FDA 483 Alcami Corporation - Form 483, 2007-03-14
March, 2006 FDA 483 Unigene Laboratories, Inc. - Form 483, 2006-03-21
March, 2001 FDA 483 OHM LABORATORIES INC. - Form 483, 2001-03-15
November, 2003 EIR Sandoz Inc. - EIR, 2003-11-18
September, 2003 EIR Daiichi Sankyo, Inc. - EIR, 2003-09-23
August, 2009 FDA 483 Response Apotex Inc. - Form 483R, 2009-09-03
February, 2002 FDA 483 Able Laboratories, Inc. - Form 483, 2002-02-11
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-01
September, 2001 EIR Bentley Laboratories, LLC - EIR, 2001-09-20
May, 2003 FDA 483 Janssen Pharmaceuticals Inc. - Form 483, 2003-05-19
October, 2003 EIR Par Pharmaceutical Companies, Inc. - EIR, 2003-10-28
August, 2004 EIR Able Laboratories Inc. - EIR, 2004-08-04
March, 2003 FDA 483 Response Able Laboratories Inc. - Form 483R, 2003-03-19
November, 2001 EIR Intergel - EIR, 2001-11-21
July, 2003 FDA 483 Par Pharmaceutical Companies, Inc. - Form 483, 2003-07-17
November, 2004 EIR Astellas Pharma Inc. - EIR, 2004-12-16
March, 2003 FDA 483 Able Laboratories Inc. - Form 483, 2003-03-14
May, 2002 EIR Nexeo Solutions, LLC. - EIR, 2002-05-31
February, 2002 FDA 483 Aspire Pharmaceuticals Inc. - Form 483, 2002-02-15
February, 2002 EIR Aspire Pharmaceuticals Inc. - EIR, 2002-02-15
May, 2003 EIR Janssen Pharmaceuticals Inc. - EIR, 2003-05-19
October, 2005 FDA 483 Sun Pharmaceutical Industries Ltd. - Form 483, 2005-10-27
November, 2002 EIR LTS Lohmann Therapy Systems Corp. - EIR, 2002-11-07
July, 2001 FDA 483 Response Blispak, Inc. - Form 483R, 2001-07-13
December, 2005 EIR Ohm Laboratories Inc. - EIR, 2005-12-20
December, 2001 EIR Merck, Inc. - EIR, 2001-12-19
September, 2002 EIR Merck Sharp & Dohme LLC - EIR, 2002-09-27
October, 2003 FDA 483 DERMARITE INDUSTRIES, LLC - Form 483, 2003-10-09

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