FDA Investigator Michael R Klapal

Michael R Klapal has inspections in 6 countries as of 13 Sep 2023. Michael R Klapal has collaborated with a combinined 6700 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
119
Last Inspection Date:
13 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
100002004
Country:
United States of America, Canada, Germany, Australia, India, Ireland
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Aditi S Thakur, Alberto A Viciedo, Alicia M Mozzachio, Allen Lou, Amy L Singer, Amy M Codella, Amy M Cramer, Amy N Chen, Anastasia I Offordile, Angela E Glenn, Anita R Michael, Ankur C Patel, Ann Marie Montemurro, Annemarie B Randow, Annemarie Bodnar, Annette Melendez, Anthony J Donato, Anthony M Criscuolo, Jr, Arlene M Badillo, Ashley N Queen, PhD, Atul J Agrawal, Azza Talaat, Barbara J Maulfair, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Barbara M Frazier, Bijoy Panicker, Binh T Nguyen, Brandon M Kurjanowicz, Brenda S Zimmer, PhD, Bryan L Mcguckin, Burnell M Henry, Byungja E Marciante, Byunja E Marciante, Carl A Perez, Carl E Lovrich, Carrie A Hughes, Cary Greene, Caryn M Mcnab, Cassandra L Abellard, Charles I Ann, Charles J Chacko, Charles L Larson, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Chiang Syin, PhD, Christina Capacci Daniel, PhD, Christina N Maurino, Christine M Cerenzio, Colin E Tack, Craig W Swanson, Cynthia A Palmer, Cynthia Jim, CSO, Cynthia L Rakestraw, Daniel J Grabicki, Daniel J Lahar, Daniel J Mechenbier, Daniel J Min, Daniel J Roberts, Darren S Brown, Daryl A Dewoskin, David A Oluwo, David J Hafner, Dawn L Wydner, Deborah B Goffman, Deborah B Nixon, Denise M Digiulio, Denise M Visco, Investigator, Dennis Cantellops Paite, Dhaval H Patel, Diane L Raccasi, Dinesh Kumar, Doan T Nguyen, PharmD, Don H Bark, PhD, Doreen P Gubbay, Douglas C Kovace, Douglas C Kovacs, Dr. Carmelo Rosa, Dr. Robert C Horan, MD, E Marciante, Edmund F Mrak, Jr, Edwin Martinez, Eileen A Liu, Emest F Bizjak, Emily A Walters, Emmanuel J Ramos, Eric J Cunningham, Eric Rothschild, Erica L Nicoll, Erin D Mccaffery, Erin D Mccaffrery, Farhana Khan, Felix Maldonado, Frank J Marciniak, Frank Wackes, Fred Razzaghi, Frederick Razzaghi, Gajendiran Mahadevan, PhD, Gayle S Lawson, George Pyramides, Gianine E Delade, Gianine E Tompkins, Gladys B Casper, Gregory E Beichner, Guerlain Ulysse, Haitao Li, Hala L Selby, Hala Lj Whetstone, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, James M Mason, James R Birkenstamm, Janet A Rajan, Javier O Vega, Jawaid Hamid, Jay T Wong, Jean Blackston Hill, Jean Blackstone Hill, Jean M Kelahan, Jean M Mulinde, MD, Jeffrey J Ebersole, Jennifer D Hollstrom, Jennifer Macmillan, Jeremy W Rotton, Jessica M Monteiro, Jessica S Estriplet, Jie He, Jill M Sooter, Jill Mielziner, Jo Annc Declement, Joey V Quitania, Jogy George, Jonathan S Helfgott, Jonee J Mearns, Jose A Moreno, Jose Acruz Gonzalez, Jose E Melendez, DDC, Jose M Cayuela, Jose O Hernandez, Jose Ohernandez Guzman, Jose R Lopez, Joseph F Mcginnis, RPh, Joseph Mcginnis, Joseph R Hatcher, Josh Renzon Ramilo, Joshua C Schafer, Joshua P Wireman, Jot R Klena, Joy Rkozlowski Klena, Juanita P Versace, Julianne C Mccullough, Junho Pak, Justin A Boyd, Justine Tomasso, Karen A Briggs, Karen E D'orazio, Karishma G Gopaul, Katelyn Astaub Zamperini, Katherine D Adams, Kathleen M Jordan, Katie L Penno, Kazi Rafiquzzaman, Keith M Reilly, Kelli F Dobilas, Kelli Regente, Kendra L Brooks, Kenneth M Gordon, Kerry A Kurdilla, Kham Phommachanh, Kinh Q Mac, Ko U Min, Krishnaiah Yellela, Kristin M Abaonza, Kristina L Conroy, Kristy A Zielny, Lance M De Souza, MBA, Larry Johnson, Larry K Austin, Lata C Mathew, PhD, Lauren L Vajo, Laurimer Kuilan Torres, Lawrence R Johnson, LCDR Debra Emerson, LCDR William H Bender, Leiyun Boone, PhD, Li Li, Liatte Kreuger, PharmD, Liattle Krueger, Libia M Lugo, Linda M Hoover, Lisa B Hall, Lisa M Bellows, Lisa M Feola, Loretta Nemchik, Lorie S Hannappel, Manhar R Patel, Maotang Xhou, Maotang Zhou, PhD, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcia D Fields, Marea K Harmon, Margaret E Walsh, Margaret L Bolte, Margaret M Annes, Margaret M Sands, Maria A Bienkowski, Maria A Reed, Maria Estrella, Maria Manzoni, PhD, Marian E Ramirez, Marianela Aponte Cruz, Marie A Fadden, Marie Bbuen Bigornia, Marjorie L Davis, Marlene G Swider, Mary Jeanet Mcgarry, Mary R Kirker, Matthew A Spataro, Mayar M Mussa, Meena Bansal Gupta, PhD, Melba T Rivera, Melba Trivera Clavell, Melissa A Zuppe, Melissa B Libby, Melissa D Ray, Melissa T Roy, Meredith L Sheridan, Merril E Racke, Meyer J Slobotsky, Michael J Diskin, Michael L Casner, Michael R Goga, Michael Serrano, Michael Shanks, MS, Michael Skelly, Michele Gottshall, Michele L Forster, PhD, Miguel G Manzano, Mihaly S Ligmond, Milva E Melendez, Mindy M Chou, Monica Cburgos Garcia, Monika Borkowska, Mra Mcculloughj, Myriam M Sosa, Nailing Zhang, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Natasha Gupta, Neal L Adams, Nebil A Oumer, Nerizza B Guerin, Nicholas A Violand, Nicholas L Paulin, Nicole A Lloyd, Niketa Patel, Nikki S Ramirez, Noreen Muniz, Nyungja E Marciente, Omotunde O Osunsanmi, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul L Bellamy, Paul Mouris, Paula J Bretz, Perry H Gambrell, Peter E Baker, Peter R Lenahan, Phares O Okelo, Philip F Istafanos, DMV, MS, Prabhu P Raju, Pushpa S Jayasekara, Qin Xu, Rafael Nevarez Nieves, Ralph H Vocque, Ramon A Hernandez, Raymond T Oji, Rebecca Parrilla, Regina T Brown, Remache, Richard J Muzeni, Richard L Rutherford, Richard W Thornton, Richard W Thorntton, Rita K Kabaso, Robert D Tollefsen, Robert G Ruff, Robert Sharpnack, Robin P Mathew, Rochelle K Kimmel, Rose Ljean Mary, Russell J Glapion, Russell K Riley, Sachinkumar V Patel, Saleem A Akhtar, Sam Pepe, Samina S Khan, Samir C Gala, Samuel Mindaye, Santos E Camara, Sarah A Hassas, Sarah E Mcmullen, Sarah Forney, Satheesh K Podaralla, Scott J Lewis, Scott T Ballard, Sena G Dissmeyer, Shahla Parvizi, Shannon A Gregory, Sharon K Thoma, PharmD, Shawn E Larson, Sherry G Bous, Shirley J Berryman, Sidney B Priesmeyer, Simone E Pitts, Sinai Davis, State Agency, Stephanie A Slater, MS, Stephanie T Durso, Stephen D Brown, Stephen D Eich, Stephen J Koniers, Stephen J Mottola, Steven C Madzo, Steven D Kehoe, Steven Fong, MS, PhD, Steven M Weinman, Sunita Iyer, Susan M Jackson, Susant Hadman, Tajah L Blackburn, Tamil Arasu, PhD, Tammy M Phillips, Tania E Garcia, Tania E Vizcaino, Tara G Bizjak, Tara R Bizjak, Tara R Gooen, Tekalign Wondimu, Thomas J Arista, Thomas M Herbst, Thompsonv, Thuy T Nguyen, LCDR, Tiffani D Wilson, Tonia F Bernard, Toyin B Oladimeji, Tracey L Harris, Tracynda L Davis, Travis R Hunt, Travis S Bradley, Tressa T Lewis, Tyanna N Hadley, Unnee Ranjan, Valerie C Reed, Victor S Pacheco, Victoria Spivak, Vilmary Negron Rodriguez, Vlada Matusovsky, Wayne E Seifert, Wayne J Meyer, Wei Wang, PhD, William J Leonard, William R Chang, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Xiuju Lu, Yan Wang, Yasamin Ameri, Yvesna C Blaise, Yvins Dezan, Zakaria I Ganiyu, Zhihao Qiu (Peter), PhD, Zhijin Chen, Zonglin Hu

Michael R Klapal's Documents

Publish Date Document Type Title
December, 2013 FDA 483 Response Ascend Laboratories, LLC - Form 483R, 2013-12-23
January, 2015 EIR RICONPHARMA LLC - EIR, 2015-01-21
February, 2012 FDA 483 Unette Corporation - Form 483, 2012-02-15
February, 2013 FDA 483 Novum Pharmaceutical Research Services of Pennsylvania, Inc. - Form 483, 2013-02-19
August, 2013 FDA 483 Response ImprimisRx NJ - Form 483R, 2013-09-03
November, 2014 FDA 483 Sonar Products, Inc. - Form 483, 2014-11-13
January, 2014 FDA 483 Genzyme Corporation - Form 483, 2014-01-21
August, 2014 FDA 483 Response ACINO PRODUCTS LIMITED LIABILITY COMPANY - Form 483R, 2014-09-02
December, 2009 FDA 483 Unette Corporation - Form 483, 2009-12-30
May, 2018 FDA 483 Advanced Accelerator Applications USA, Inc. - Form 483, 2018-05-17
June, 2013 FDA 483 Hikma Pharmaceuticals USA, Inc. - Form 483, 2013-06-07
June, 2010 FDA 483 Actavis Elizabeth LLC - Form 483, 2010-06-04
May, 2014 FDA 483 Halo Pharmaceutical Inc - Form 483, 2014-05-12
December, 2008 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2008-12-22
May, 2011 FDA 483 Ex-Lax, Inc. - Form 483, 2011-05-23
April, 2013 FDA 483 The P.F. Laboratories Inc. - Form 483, 2013-04-22
December, 2013 FDA 483 Ascend Laboratories, LLC - Form 483, 2013-12-11
September, 2015 FDA 483 ImprimisRx NJ - Form 483, 2015-09-30
July, 2015 EIR ImClone Systems LLC - EIR, 2015-07-10
February, 2018 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - Form 483, 2018-02-09
February, 2013 EIR Novum Pharmaceutical Research Services of Pennsylvania, Inc. - EIR, 2013-02-19
February, 2009 FDA 483 Ohm Laboratories, Inc. - Form 483, 2009-02-19
February, 2013 FDA 483 Akorn Operating Company LLC (dba Akorn) - Form 483, 2013-02-01
July, 2012 EIR SGS Canada Inc - EIR, 2012-07-20
May, 2012 FDA 483 June Jacobs Labs, LLC - Form 483, 2012-05-16
November, 2008 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2008-11-10
November, 2013 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2013-11-13
November, 2012 FDA 483 Bipore Medical Devices, Inc. - Form 483, 2012-11-19
July, 2012 FDA 483 SGS Canada Inc - Form 483, 2012-07-20
February, 2015 FDA 483 Pfizer Healthcare India Private Limited - Form 483, 2015-02-25
February, 2014 EIR Teva Canada Limited - EIR, 2014-02-14
November, 2010 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2010-11-17
February, 2014 FDA 483 Taro Pharmaceuticals Inc. - Form 483, 2014-02-28
November, 2013 EIR Amneal Pharmaceuticals, LLC - EIR, 2013-11-13
July, 2011 FDA 483 API, Inc. - Form 483, 2011-07-15
March, 2012 FDA 483 Alcami Corporation - Form 483, 2012-03-15
March, 2012 FDA 483 Response Alcami Corporation - Form 483R, 2012-03-26
February, 2010 FDA 483 Scientech Laboratories, Inc. - Form 483, 2010-02-25
April, 2013 EIR The P.F. Laboratories Inc. - EIR, 2013-04-22
April, 2011 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2011-04-12
November, 2011 EIR J.M. Smucker LLC - EIR, 2011-11-23
February, 2009 FDA 483 Ohm Laboratories Inc. - Form 483, 2009-02-19
October, 2010 FDA 483 Sani-pure Food Laboratories Llc - Form 483, 2010-10-20
February, 2013 FDA 483 Sonar Products, Inc. - Form 483, 2013-02-15
February, 2014 EIR Taro Pharmaceuticals Inc. - EIR, 2014-02-28
August, 2009 FDA 483 Scientech Laboratories, Inc. - Form 483, 2009-08-05
February, 2013 EIR Sonar Products, Inc. - EIR, 2013-02-15
July, 2014 FDA 483 Siegfried Hameln GmbH - Form 483, 2014-07-25
July, 2013 FDA 483 ISP Sutton Laboratories - Form 483, 2013-07-11
January, 2015 FDA 483 RICONPHARMA LLC - Form 483, 2015-01-21
February, 2013 EIR Akorn Operating Company LLC (dba Akorn) - EIR, 2013-02-01
October, 2009 FDA 483 Actavis Elizabeth LLC - Form 483, 2009-10-22
June, 2014 FDA 483 Elite Laboratories, Inc. - Form 483, 2014-06-03
August, 2012 EIR HVL, LLC - EIR, 2012-08-06
November, 2013 EIR Avantor Performance Materials, LLC - EIR, 2013-11-15
August, 2010 FDA 483 Radpharm, Inc. - Form 483, 2010-09-02
January, 2013 FDA 483 Contract Coating Inc. - Form 483, 2013-01-07
May, 2009 FDA 483 Pliva, Inc. - Form 483, 2009-05-05
April, 2019 FDA 483 KVK-TECH, INC. - Form 483, 2019-04-16
January, 2011 FDA 483 Leading Pharma, LLC - Form 483, 2011-01-06
August, 2013 FDA 483 ImprimisRx NJ - Form 483, 2013-08-19
March, 2012 EIR Alcami Corporation - EIR, 2012-03-15
May, 2015 FDA 483 SOFIE Co. dba SOFIE - Form 483, 2015-05-15
March, 2015 FDA 483 DR.REDDY'S LABORATORIES LIMITED - Form 483, 2015-03-06
August, 2014 FDA 483 ACINO PRODUCTS LIMITED LIABILITY COMPANY - Form 483, 2014-08-19
February, 2009 FDA 483 OHM LABORATORIES INC. - Form 483, 2009-02-19
September, 2016 FDA 483 Ferring Production Inc. - Form 483, 2016-09-12
April, 2015 FDA 483 Halo Pharmaceutical Inc - Form 483, 2015-04-24
June, 2017 FDA 483 KVK-TECH, INC. - Form 483, 2017-06-27
January, 2012 FDA 483 Leading Pharma, LLC - Form 483, 2012-01-23
August, 2009 FDA 483 Inopak Ltd - Form 483, 2009-08-21
November, 2015 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2015-11-03
February, 2015 EIR Nelson Laboratories Fairfield Inc. - EIR, 2015-02-03
July, 2013 EIR ISP Sutton Laboratories - EIR, 2013-07-11

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