FDA Investigator Joy Rkozlowski Klena

Joy Rkozlowski Klena has inspections in 3 countries as of 03 Nov 2023. Joy Rkozlowski Klena has collaborated with a combinined 4639 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:

132

Last Inspection Date:

03 Nov 2023

Investigator Role:

FDA Investigation Participant

Redica ID:

100005913

Country:

United States of America, Canada

Co-Investigator(s):

Addam S Reynolds, Adetutu M Gidado, Alanna Lmussawwir Bias, Alberto A Viciedo, Allen Lou, Amy L Singer, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia I Offordile, Ankur C Patel, Ann Marie Montemurro, Ann Marie Schofield, Annemarie B Randow, Annemarie Bodnar, Annet R Rajan, Anthony J Donato, Anthony M Criscuolo, Jr, Arsen Karapetyan, Ashley A Mutawakkil, Ashley J Burns, Atul J Agrawal, Barbara J Maulfair, Barbara J Maulfar, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Barbara L Rellahan, PhD, Bei Yu, Binh T Nguyen, Brett R Havranek, Brian D Nicholson, Byungja E Marciante, Cara M Minelli, Carla A Norris, Cary Greene, Cassandra L Abellard, Charles A Snipes, PhD, Charles J Chacko, Charles M Edwards, Christina P Burkhart, Christine M Cerenzio, Christopher T Middendorf, Claire M Minden, Colin E Tack, Constantin Y Philopoulos, Cynthia F Kleppinger, MD, Cynthia Jim, CSO, Dale A Nyberg, Dan Grabicki, Daniel J Grabicki, Daniel J Min, David A Oluwo, David E Bailey, Dawn L Wydner, Deborah B Goffman, Deborah B Nixon, Denise M Visco, Investigator, Devaughn Edwards, Devon Jenkins, Dinesh Kumar, Donald L Lech, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Robert C Horan, MD, Dr. Zhou Chen (nmi), MD PhD, Edmund F Mrak, Jr, Elaine E Gilfillan, Emest F Bizjak, Emmanuel J Ramos, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Ernie F Bizkaj, Frank J Marciniak, Frank Wackes, Fred Razzaghi, Frederick Razzaghi, George Pyramides, Gianine E Tompkins, Gobiga Vanniyasingam, Graeme E Price, Guerlain Ulysse, Haitao Li, Helen B Ricalde, Helen Verdel, Israel Santiago, OCM, Jacqueline Mdiaz Albertini, James L Finn, James R Birkenstamm, James R Evans, Jamie L Dion, Janet A Rajan, Jawaid Hamid, Jay B Shah, Jean Blackston Hill, Jean Blackstone Hill, Jean M Kelahan, Jean M Mulinde, MD, Jeffrey J Ebersole, Jennifer Macmillan, Jessica M Monteiro, Joanne Heim, Jogy George, Jonathan G Matrisciano, Jonathan S Helfgott, Jonee J Mearns, Jose E Melendez, DDC, Jose M Cayuela, Joseph F Mcginnis, RPh, Joseph Mcginnis, Joshua C Schafer, Jot R Klena, Joy R Kelna, Joy R Kozlowski, Julie D Bringger, Justine Tomasso, Karen E D'orazio, Keith M Reilly, Kelli F Dobilas, Kelli Regente, Kelly I Anderson, Kevin Obrien, Kevin P Foley, Kinh Q Mac, Ko U Min, Kristen E Rescigno, Kristina L Conroy, Kristy A Zielny, Kristy E Zuroski, Krystyna M Kitson, Laishan L Lam, Larry K Austin, Lata C Mathew, PhD, Laura Fontan, MS, Lauren L Vajo, Lawrence R Johnson, Lenahan Lenahan, Peter R, Li Li, Liatte Kreuger, PharmD, Lily Y Koo, Linda Thai, Lisa B Hall, Lisa Harlan, Lisa M Bellows, Logan T Williams, Loretta Nemchik, LT Tamara J Henderson, Luis A Dasta, Maotang Xhou, Maotang Zhou, PhD, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Maria A Bienkowski, Maria A Reed, Maria Estrella, Marie T Falcone, Matthew A Spataro, Matthew Sparato, Maureen A Wentzel, Melba T Rivera, Melba Trivera Clavell, Melissa B Libby, Melissa T Roy, Meredith L Sheridan, Merril E Racke, Meyer J Slobotsky, Michael R Klapal, Michael Rosner, Michael Serrano, Michelle M Parisi, Mihaela Jason, Mihaly S Ligmond, Mindy M Chou, Monika Borkowska, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Natasha Gupta, Nerizza B Guerin, Nicholas A Violand, Niketa Patel, Nikki S Ramirez, Nina Yang, Niraj Mehta, Noreen Muniz, Odera I Ekwunife, Omotunde O Osunsanmi, Patricia H Dlugosz, Patrick C Klotzbuecher, Patrick L Wisor, Paul L Bellamy, Paula J Bretz, Peter R Lenahan, Phares O Okelo, Prabhu P Raju, Pratibha Bhat, Rafeeq A Habeeb, Ralph A Erickson, Ramanda C Gregory, Raymond L Cheung, Rebecca Rodriguez, Regina T Brown, Richard J Muzeni, Richard W Thornton, Richard W Thorntton, Ricki A Chase, Ricki Achase Off, Robert C Steyert, Robert D Tollefsen, Robert G Ruff, Robert Sharpnack, Robert W Calais, Robin P Mathew, Rochelle L Cross, Rosario D'costa, Rose Ljean Mary, Russell J Glapion, Sachinkumar V Patel, Saleem A Akhtar, Samir C Gala, Sandra Kershaw, Sarah Adella Fave, Sarah Forney, Satheesh K Podaralla, Sayyem H Akbar, Sean G Casey, Shelby N Turner, Sherri J Liu, Shirley H Isbill, Shirley S Wen, Sidney B Priesmeyer, Sinai Davis, State Agency, Stelios C Tsinontides, Stephanie T Durso, Stephen D Brown, Stephen J Mottola, Susan M Halsted, Tamil Arasu, PhD, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Teresa I Navas, Thomas J Arista, Tonia F Bernard, Travis R Hunt, Unnee Ranjan, Valerie C Reed, Victoria Spivak, Vincent F Cafiso, Vlada Matusovsky, Wayne J Meyer, William A Warnick, William Chang, William R Chang, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Yvesna C Blaise, Yvins Dezan, Zakaria I Ganiyu, Zhaohui Ye, Zhijin Chen, Zhongren Wu

Joy Rkozlowski Klena's Documents

Publish Date	Document Type	Title
August, 2002	FDA 483 Response	Scientech Laboratories, Inc. - Form 483R, 2002-09-04
June, 2003	EIR	A. Pharma Usa, Inc. - EIR, 2003-06-02
June, 2003	FDA 483	Perritt Laboratories, Inc - Form 483, 2003-06-11
January, 2005	EIR	Able Laboratories, Inc. - EIR, 2005-01-05
June, 2006	FDA 483	OHM LABORATORIES INC. - Form 483, 2006-06-28
June, 2006	FDA 483 Response	OHM LABORATORIES INC. - Form 483R, 2006-07-31
January, 2001	FDA 483 Response	Merck, Inc. - Form 483R, 2001-02-16
June, 2003	EIR	Perritt Laboratories, Inc - EIR, 2003-06-11
February, 2002	FDA 483	Tevco Enterprises, Inc. - Form 483, 2002-02-27
February, 2000	EIR	E.R. Squibb & Sons, L.L.C. - EIR, 2000-02-02
February, 2004	FDA 483	Glaxo Smith Kline - Form 483, 2004-02-25
March, 2000	FDA 483	Cyalume Specialty Products - Form 483, 2000-03-16
November, 2007	EIR	OHM LABORATORIES INC. - EIR, 2007-11-26
November, 2006	FDA 483	Medico Labs, Inc. - Form 483, 2006-11-16
May, 2003	EIR	BRACCO DIAGNOSTICS INC - EIR, 2003-05-01
December, 2001	EIR	Hoffmann La Roche Inc - EIR, 2001-12-12
August, 2007	FDA 483	Sunrise Pharmaceutical Inc - Form 483, 2007-08-20
January, 2001	EIR	Merck, Inc. - EIR, 2001-01-19
November, 2007	FDA 483 Response	OHM LABORATORIES INC. - Form 483R, 2007-12-17
January, 2004	EIR	Jubilant HollisterStier General Partnership. - EIR, 2004-02-11
March, 2004	EIR	Baxter Healthcare Corporation - EIR, 2004-03-11
July, 2003	FDA 483 Response	Enzon Pharmaceuticals, Inc - Form 483R, 2004-05-10
October, 2003	EIR	Rand Diversified LLC - EIR, 2003-10-15
October, 2003	EIR	VILS Pharma Coating LLC - EIR, 2003-10-22
September, 2006	EIR	Ohm Laboratories Inc. - EIR, 2006-09-06
June, 2003	FDA 483	A. Pharma Usa, Inc. - Form 483, 2003-06-02
February, 2004	EIR	Glaxo Smith Kline - EIR, 2004-02-25
February, 2005	FDA 483	Able Laboratories Inc. - Form 483, 2005-02-22
August, 2004	EIR	Par Pharmaceutical Companies, Inc. - EIR, 2004-09-17
September, 2002	EIR	Able Laboratories Inc. - EIR, 2002-09-18
July, 2006	FDA 483	Micro Chem Laboratories - Form 483, 2006-07-20
June, 2006	EIR	OHM LABORATORIES INC. - EIR, 2006-06-28
January, 2004	FDA 483 Response	Jubilant HollisterStier General Partnership. - Form 483R, 2004-02-11
January, 2004	FDA 483	Jubilant HollisterStier General Partnership. - Form 483, 2004-01-20
December, 2003	FDA 483	Actavis Elizabeth LLC - Form 483, 2003-12-15
January, 2001	FDA 483	Merck & Co., Inc. - Form 483, 2001-01-19
February, 2002	FDA 483 Response	Merck, Inc. - Form 483R, 2002-03-27
November, 2007	FDA 483	OHM LABORATORIES INC. - Form 483, 2007-11-26
September, 2001	EIR	Kinder Morgan Liquids Terminals, LLC - EIR, 2001-09-06
March, 2000	EIR	Cyalume Specialty Products - EIR, 2000-03-16
April, 2002	FDA 483 Response	Reheis Inc - Form 483R, 2002-05-10
August, 2002	FDA 483	Scientech Laboratories, Inc. - Form 483, 2002-08-07
September, 2003	FDA 483 Response	Hoffmann La Roche Inc - Form 483R, 2003-09-30
January, 2007	EIR	Cordis Corporation - EIR, 2007-01-12
February, 2005	FDA 483 Response	Able Laboratories Inc. - Form 483R, 2005-03-21
November, 2002	EIR	Cosette Pharmaceuticals, Inc. - EIR, 2002-11-13
July, 2003	FDA 483	Enzon Pharmaceuticals, Inc - Form 483, 2003-07-10
May, 2000	FDA 483	OHM LABORATORIES INC. - Form 483, 2000-05-09
October, 2001	FDA 483	Duramed Pharmaceuticals, Inc. - Form 483, 2001-10-12
June, 2006	FDA 483 Response	Ohm Laboratories Inc. - Form 483R, 2006-06-28
June, 2006	FDA 483	Ohm Laboratories Inc. - Form 483, 2006-06-19
July, 2003	EIR	GE Healthcare Inc. - EIR, 2003-07-23
April, 2002	FDA 483	Reheis Inc - Form 483, 2002-04-22
October, 2003	FDA 483	VILS Pharma Coating LLC - Form 483, 2003-10-22
September, 2003	EIR	Hoffmann La Roche Inc - EIR, 2003-09-10
August, 2000	FDA 483	Organon USA Inc. - Form 483, 2000-08-23
April, 2003	EIR	Halo Pharmaceutical Inc - EIR, 2003-04-10
December, 2001	FDA 483	Hoffmann La Roche Inc - Form 483, 2001-12-12
March, 2008	FDA 483	Advent Pharmaceuticals Inc. - Form 483, 2008-03-05
April, 2001	EIR	Guardian Drug Company - EIR, 2001-04-09
June, 2000	EIR	New Chemic (U.S.), Inc. - EIR, 2000-06-14
January, 2000	FDA 483	Enzon Pharmaceuticals, Inc - Form 483, 2000-01-20
July, 2003	EIR	Enzon Pharmaceuticals, Inc - EIR, 2003-07-10
October, 2000	EIR	Duramed Pharmaceuticals Inc - EIR, 2000-10-19
June, 2002	EIR	Avantor Performance Materials, LLC - EIR, 2002-06-27
October, 2000	FDA 483	Duramed Pharmaceuticals, Inc. - Form 483, 2000-10-19
March, 2007	EIR	ACINO PRODUCTS LIMITED LIABILITY COMPANY - EIR, 2007-03-12
January, 2008	FDA 483	Nexmed USA Inc. - Form 483, 2008-01-15
June, 2004	EIR	Merck, Inc. - EIR, 2004-06-07
May, 2004	EIR	Enzon Pharmaceuticals, Inc - EIR, 2004-05-24
August, 2001	EIR	Able Laboratories Inc. - EIR, 2001-08-22
July, 2004	FDA 483	Somerville Acquisitions Co., Inc. - Form 483, 2004-07-21
April, 2003	FDA 483	Halo Pharmaceutical Inc - Form 483, 2003-04-10
October, 2001	EIR	Duramed Pharmaceuticals Inc - EIR, 2001-10-12
February, 2002	FDA 483	Merck, Inc. - Form 483, 2002-02-08
December, 2003	EIR	Actavis Elizabeth LLC - EIR, 2003-12-15
August, 2001	FDA 483	Enzon Pharmaceuticals, Inc - Form 483, 2001-08-02
May, 2000	EIR	OHM LABORATORIES INC. - EIR, 2000-05-09
June, 2006	EIR	Ohm Laboratories Inc. - EIR, 2006-06-19
January, 2002	EIR	Able Laboratories Inc. - EIR, 2002-01-10
November, 2002	FDA 483	Cosette Pharmaceuticals, Inc. - Form 483, 2002-11-13
April, 2001	FDA 483	Akorn Operating Company LLC (dba Akorn) - Form 483, 2001-04-24
March, 2001	FDA 483	Glaxo Smithkline - Form 483, 2001-03-15
August, 2004	FDA 483	DSHealthcare Inc. - Form 483, 2004-08-05
February, 2005	EIR	Able Laboratories Inc. - EIR, 2005-02-22
July, 2004	EIR	Somerville Acquisitions Co., Inc. - EIR, 2004-09-01
July, 2007	EIR	Vantage Specialty Ingredients, Inc - EIR, 2007-07-17
April, 2003	FDA 483 Response	Halo Pharmaceutical Inc - Form 483R, 2003-04-25
February, 2002	EIR	Merck, Inc. - EIR, 2002-02-08
May, 2004	EIR	IAM ACQUISITIONS, LLC - EIR, 2004-05-27
April, 2006	FDA 483	Janssen Pharmaceuticals Inc. - Form 483, 2006-04-11
August, 2000	FDA 483 Response	Organon USA Inc. - Form 483R, 2000-09-07
May, 2006	FDA 483	Ohm Laboratories Inc - Form 483, 2006-05-01
April, 2002	EIR	Reheis Inc - EIR, 2002-04-22
December, 2003	FDA 483 Response	Actavis Elizabeth LLC - Form 483R, 2004-01-09
February, 2007	FDA 483	Akorn Operating Company LLC (dba Akorn) - Form 483, 2007-02-06
June, 2002	FDA 483 Response	Avantor Performance Materials, LLC - Form 483R, 2002-07-24
September, 2006	FDA 483	Apicore US LLC - Form 483, 2006-09-25
January, 2001	FDA 483	Merck, Inc. - Form 483, 2001-01-19
April, 2006	EIR	Ortho Clinical Diagnostics - EIR, 2006-04-11
August, 2006	EIR	Ohm Laboratories Inc. - EIR, 2006-08-16
September, 2003	FDA 483	Hoffmann La Roche Inc - Form 483, 2003-09-10
April, 2006	EIR	Ohm Laboratories, Inc. - EIR, 2006-04-24
April, 2001	FDA 483	Guardian Drug Company - Form 483, 2001-04-09
March, 2007	FDA 483	ACINO PRODUCTS LIMITED LIABILITY COMPANY - Form 483, 2007-03-12

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