FDA Investigator Sonya L Karsik

Sonya L Karsik has inspections in 13 countries as of 06 Nov 2023. Sonya L Karsik has collaborated with a combinined 5631 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
336
Last Inspection Date:
06 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
100002177
Country:
United States of America, Mexico, France, Italy, Germany, China, Costa Rica, Japan, Dominican Republic, Canada, Taiwan, Switzerland
Co-Investigator(s):
A Williams, Ademola O Daramola, Aimee K Contreras, Alan L Truong, Alan P Kurtzberg, Albert Rodriguez, Alexandra B Pitkin, Alexandria L Capuano, Aliza Chalapong Asawesna, Allen F Hall, Amalia C Himaya, Amanda L Fyles, Amir Alavi, Ana Djurdjevic, Anderson, Andrew K Haack, PhD, Angela Shepas, Angelica G Aziz, Annette Melendez, Anthony G Emerson, Anthony Inocencio, Arie C Menachem, Arsen Karapetyan, Ashar P Parikh, Babajide Michael Osunsanmi, Bichsa T Tran, Binh T Nguyen, Bonnie I Needleman, Bowman, Brandon L Blakely, Brandon R Boone, Brentley S Collins, Brian A Perkins, Brian P Putz, Brian Ravitch, Bryan A Galvez, Burnsb, Bush, Carl A Huffman, III, Carla J Lundi, Carr Sharpe, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Cathryn M Groehnert, CDR Cecily Jones, CDR Sean T Creighton, Celena Ngo, Celeta S Coves, Chad E Schmear, Charles L Larson, Chelsea N Sealey, Cheryl D Mccall, Christine I Shaw, Christopher J Freebairn, Christopher R Czajka, Comyar Shoghi, Courtney N Long, Creighton T Tuzon, Cynthia L Gorveatt, Daniel J Lahar, Daniel J Roberts, Daniel R Solis, Dannie E Rowland, Darren S Brown, David G Whitman, David Serrano, David Y Hernandez, Davis, Deborah A Greco, Debra J Fracassa, Decarlos A Gomez, Dejon N Harris, Dellarese L Herbert, Denise R Beuttenmuller, Dennis G Poertner, Desiree C Iya, Diana L Ayala, Diane Cvan Leeuwen, Diane R Weidley, Dianiris C Ayala, Donna Ltartaglino Besone, Donna Mwilliams Hill, Doretha M Tonkins, Durell L Giles, Dyana K Stone, Dylan R Jock, Elizabeth A Girard, Elizabeth Ad Girard, Eric C Schmitt, Eric J Cunningham, Eric W Anderson, Erik D Sandvig, Esther B Gamallo Herrera, F Alex Slizza, Fe Q Reyes, Finn A Slizza, Francis J Eng, Francisco, Gabriel M Guevarra, Garciam, Gene D Arcy, Geraldine M Peregrin, Harperd, Heidy C Perales, Henry E Carrillo, Herminio C Francisco, Himanshu Gupta, PhD, Hoover, Hossein Khorshidi, PhD, Hung H Do, MS, Iris C Macinnes, Ivar J Sohn, Jacqueline M Bowling, James A Barreto, James B Arnett, James E Bentson, James M Simpson, James P Stallings, James R Fleckenstein, James R Heckenstein, Jamie M Du, Jane S Wernberg, Janet Pulver, Jasmine N Thompson, Jeanne M Morris, Jeffrey P Raimondi, Jennifer M Gogley, Jennifer S Ness, Jeremy Beber, Jessica B Clark, Jinnie Kokiatkulkij, Jocelyn E Massey, Jocelyn E Sparks, Joey V Quitania, John A Gonzales, John A Gonzalez, John A Liu, John L Stevens, John R Myung, Joseph Brady, Joseph C Francisco, Joseph H Lam, Joshua E Yao, Joshua P Wireman, Juan J Casado, Juanita Banuelos, Juanj N Wu, Juanj Wu, Jude C Dikes, Judy C Nepsa, Julia Ventura, K Gonzlez, Ka L Wong, Karen L Bauer, Karen M Montgomery (KMM), Karen P Langer, Kari M Johansen, Katherine E Jacobitz, Kelley, Kellie L Thommes, RN, Kelvin Cheung, Kelvin X Sanders, Kevin N Tran, Kham Phommachanh, Khoa Nathanv Tran, Kim Lthomas Cruse, Kimberly Lewandowski Walker, Kimberly M Lichter, Kirsten S Tharp, Kirtida Patel, Krista K Petersen, Lakecha N Lewis, Langer, Lanita F Kelley, Laureen M Geniusz, Laurissa S Flowers, Laverne Kimble, Leonard H Lavi, Lequita M Mayhew, Lilly O Barton, Liming Zhang, Linda Galindo, Linda Thai, Ling Yul Liu, Lisa Shin, Lori J Silverstein, Lori S Lawless, Louis B Cencetti, Louise B Cencetti, Lydia S Chan, Marcus F Yambot, Marie Falcone, Marie T Falcone, Mark A Tucker, Mark C Saale, Mark W Babbitt, Marlo Ianm Alintanahin, Matthew D Schnittker, Matthew J Johnson, Matthew M Vernon, Maxyne T Lam, Mei Chen Mu, Melinda L Rice, Melissa I Michurski, Michael A Charles, Michael D Garcia, Michael D Kawalek, Michael F Schuette, Michael G Mayfield, Michael S Araneta, Mihaly S Ligmond, Minh D Phan, Minh Phan, Monica J Wilkins, Monica R Maxwell, Mpris Inspector, Msdap Gonzlezk, Nancy Bogdanovic, Nancy E Byerly, Nancy E Smith, Natalie J Ayoub, Naveen B Walker, Nianna C Burns, Nicholas L Hunt, Nobuko H Katagiri, Norman Wong, Olga Simakova, Omotunde O Osunsanmi, Pamela Y Lee, Patricia F Alberico, Paula J Bretz, Phal K Chhun, Philip F Istafanos, DMV, MS, Phillip L Toy, Prabhu P Raju, Rachel E Hauser, Raymond T Oji, Raymond W Brullo, Rebecca T Davis, Richard Heath Coats, Richard Jay Tucker, RS, Richard L Rutherford, Richard T Riggie, Richard W Tubb, Richmond K Yip, Robert C Coleman, Robert S Sweeton, Roy Baby, Samson O Oluseye, Sandersk, Sandra L Shire, DMD, MPA, Santiago Gallardo Johnson, Sara H Gabel, Sara Jdent Acosta, Sara M Richardson, Sarah A Hassas, Sarah Forney, Satheesh Thomas, Scott K Zika, Scott T Ballard, Sean P Desbrow, Selene T Torres, Sergio Chavez (NMI), Shaquenta Y Perkins, Sherry L Secrist, BLT DO, Sonia R Peterson, Sonya L Kareik, Sparky L Bartee, Srinivas R Chennamaneni, PhD, State Agency, Stephanie A Slater, MS, Stephen R Souza, Steven E Porter, Jr, Steven R Ziser, Stuart W Russell, Sudipan Karmakar, Sue Lee Chan, Sumit Sen, Sundy Ven, Sunitha K Rajaram, PhD, Susan D Yuscius, Susan K Bain, Susan M North, Suzanne M Healy, Suzie L Kent, Taichun Qin, PhD, Tamala P Bogan, Tamala P Magee, Tamara L Alexander, Tania Y Hall, Teresa Jimenez, Terrance L Thomas, Terri E Gibson, Terri L Dodds, Thai T Duong, Thanh M Andrews, Thao T Kwan, Theresa Kirkham (NMI), Thomas R Beilke, Timothy P Lafave, Tony J Wu, Tony T Yang, Tracey T Duong, Trudy Papson, Trudy R Papson, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), Vashti E Bocker, Vickie L Anderson, Victor H Loo, Vien Q Le, Vijaya L Simhadri, Virgilio F Pacio, CSO, Walden H Lee, Wendy R Blame, William J Leonard, William S Vitale, Wr Bowman, Xiaohui Shen, Xiaojun Yan, Yasamin Ameri, Yumi J Hiramine, Yvette E Guillermo, Yvette Mlacour Davis, Yvonne C Wilkes, Yvonne T Lacour, Yvonne Y Wu, Zachary A Bogorad

Sonya L Karsik's Documents

Publish Date Document Type Title
August, 2013 FDA 483 C.L.R. Medicals International, Inc. - Form 483, 2013-08-13
November, 2011 FDA 483 Caldon Bioscience Inc - Form 483, 2011-11-01
February, 2014 FDA 483 Abbott Vascular - Form 483, 2014-02-11
September, 2009 EIR Advanced Sterilization Products - EIR, 2009-09-28
September, 2019 FDA 483 Response Diamond Wipes International, Inc. - Form 483R, 2019-10-07
September, 2011 FDA 483 Orthopedic Alliance LLC - Form 483, 2011-09-23
February, 2015 FDA 483 Kyocera Medical Technologies, Inc - Form 483, 2015-02-13
March, 2017 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2017-03-31
May, 2005 FDA 483 OASIS Medical, Inc. - Form 483, 2005-05-19
April, 2008 EIR Amphastar Pharmaceuticals, Inc. - EIR, 2008-04-09
October, 2002 FDA 483 Cosway Company, Inc. - Form 483, 2002-10-25
December, 2003 EIR Truer Medical Inc - EIR, 2003-12-23
September, 2011 FDA 483 Spinal Solutions, LLC - Form 483, 2011-09-15
April, 2017 FDA 483 Sparsha Pharma USA, Inc. - Form 483, 2017-04-28
September, 2003 FDA 483 Del Mar Reynolds Medical Incorporated - Form 483, 2003-09-10
September, 2019 EIR Diamond Wipes International, Inc. - EIR, 2019-10-01
May, 2014 FDA 483 Respironics California, LLC - Form 483, 2014-05-08
June, 2023 FDA 483 Hardy Diagnostics - Form 483, 2023-07-13
December, 2004 EIR Pond, Malcolm MD - EIR, 2004-12-03
November, 2013 EIR Advanced Sterilization Products - EIR, 2013-11-15
January, 2020 FDA 483 Scientific Pharmaceuticals, Inc. - Form 483, 2020-01-09
September, 2012 FDA 483 Spinal Solutions, LLC - Form 483, 2012-09-11
May, 2018 FDA 483 Acro Biotech Inc. - Form 483, 2018-05-01
November, 2014 EIR WHPM Inc. - EIR, 2014-11-13
December, 2003 FDA 483 Truer Medical Inc - Form 483, 2003-12-23
October, 2021 FDA 483 Orchestrate Orthodontic Technologies, Inc. - Form 483, 2021-10-28
February, 2017 FDA 483 International Medication Systems, Ltd. - Form 483, 2017-02-09
June, 2003 EIR Reach Global Industries Inc - EIR, 2003-06-13
March, 2016 FDA 483 Pacific Consolidated Industries LLC - Form 483, 2016-03-24
November, 2007 FDA 483 Abbott Vascular - Form 483, 2007-11-15
December, 2004 FDA 483 Pond, Malcolm MD - Form 483, 2004-12-03
September, 2019 FDA 483 Diamond Wipes International, Inc. - Form 483, 2019-09-06
October, 2011 FDA 483 Advanced Infusion Inc - Form 483, 2011-10-14
September, 2021 FDA 483 Micro Therapeutics, Inc. - Form 483, 2021-09-17
January, 2014 FDA 483 Carl Zeiss Meditec Production, LLC - Form 483, 2014-01-08
March, 2009 FDA 483 Circuit Tree Medical Inc - Form 483, 2009-03-04
June, 2017 FDA 483 eResearchTechnology GmbH - Form 483, 2017-06-29
April, 2008 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2008-04-09
September, 2012 FDA 483 Response Spinal Solutions, LLC - Form 483R, 2012-10-01
March, 2007 FDA 483 Response Staar Surgical Co. - Form 483R, 2007-04-05
December, 2016 EIR Sterigenics U.S., LLC - EIR, 2016-12-02
August, 2015 FDA 483 International Medication Systems, Ltd. - Form 483, 2015-08-10
April, 2019 FDA 483 Nihon Kohden America Inc - Form 483, 2019-04-30
November, 2013 FDA 483 Advanced Sterilization Products - Form 483, 2013-11-15
February, 2022 FDA 483 WHPM Inc. - Form 483, 2022-02-28
February, 2011 FDA 483 KC Pharmaceuticals, Inc. - Form 483, 2011-02-14
September, 2010 FDA 483 American National Red Cross - Form 483, 2010-09-24
May, 2010 FDA 483 Nobel Biocare Usa Llc - Form 483, 2010-05-14
July, 2012 EIR Crowder Machine & Tool - EIR, 2012-07-30
December, 2019 FDA 483 Mark Berman, M.D. - Form 483, 2019-12-05
January, 2020 FDA 483 Peerless Injection Molding, LLC - Form 483, 2020-01-28
June, 2017 EIR eResearchTechnology GmbH - EIR, 2017-06-29
September, 2011 FDA 483 Response Orthopedic Alliance LLC - Form 483R, 2011-09-30
May, 2009 FDA 483 Neo Imagery Technologies, Inc. - Form 483, 2009-05-01
September, 2011 FDA 483 Response Spinal Solutions, LLC - Form 483R, 2011-09-29
April, 2013 FDA 483 A Plus International Inc - Form 483, 2013-04-04
September, 2012 FDA 483 Orthopedic Alliance LLC - Form 483, 2012-09-11
March, 2007 EIR Staar Surgical Co. - EIR, 2007-03-14
October, 2012 EIR WHPM Inc. - EIR, 2012-10-31
October, 2011 FDA 483 Millennium Medical Technologies Inc - Form 483, 2011-10-21
December, 2003 FDA 483 Response Truer Medical Inc - Form 483R, 2004-02-17
May, 2005 EIR OASIS Medical, Inc. - EIR, 2005-05-19
September, 2004 FDA 483 Response Haemonetics Manufacturing Inc. - Form 483R, 2004-11-09
January, 2010 FDA 483 Ormco/Sybronendo - Form 483, 2010-01-20
March, 2012 FDA 483 New World Medical Inc - Form 483, 2012-03-20
September, 2012 FDA 483 Response Orthopedic Alliance LLC - Form 483R, 2012-09-26
June, 2003 FDA 483 Reach Global Industries Inc - Form 483, 2003-06-13
September, 2004 FDA 483 Haemonetics Manufacturing Inc. - Form 483, 2004-09-09
March, 2007 FDA 483 Staar Surgical Co. - Form 483, 2007-03-14
June, 2012 FDA 483 OASIS Medical, Inc. - Form 483, 2012-06-26
April, 2017 FDA 483 Response Sparsha Pharma USA, Inc. - Form 483R, 2017-05-18
May, 2019 FDA 483 Anigan, Inc. - Form 483, 2019-05-23

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