FDA Investigator Sonya L Karsik, RAC

Sonya L Karsik, RAC has conducted inspections on 336 sites in 13 countries as of 05 Jun 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
336
Last Inspection Date:
05 Jun 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, France, Mexico, Costa Rica, Germany, China, Taiwan, Japan, Korea (Republic of), Dominican Republic, Italy, Switzerland, Canada
FDA Investigators that have inspected at least one site in common with Sonya L Karsik, RAC:
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, Althea A Williams, 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, 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, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Cathleen A Carr Sharpe, 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, Crystal Monroy, 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, Dolores Harper, Donna Ltartaglino Besone, Donna Mwilliams Hill, PhD, Doretha M Tonkins, Durell L Giles, Dyana K Stone, Dylan R Jock, Elizabeth A Brown, Elizabeth Ad Girard, Eric C Schmitt, Eric J Cunningham, Eric W Anderson, Erik D Sandvig, Esther B Gamallo Herrera, Fe Q Reyes, Finn A Slizza, Francis J Eng, Francisco, Gabriel M Guevarra, Garciam, Gene D Arcy, Geraldine M Peregrin, Heidy C Perales, Henry E Carrillo, Herminio C Francisco, Himanshu Gupta, PhD, Homero W Aguilar, 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, 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 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, 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, Lanita F Kelley, Laureen M Geniusz, Laurissa S Flowers, Laverne Kimble, Leonard H Lavi, Lequita M Mayhew, Lillian S Wu, Lilly O Barton, Liming Zhang, Linda Galindo, Linda Thai, Ling Yu L Liu, Lisa Shin, Lori J Silverstein, Lori S Lawless, Louis B Cencetti, Lydia S Chan, Malgorzata G Norton, PhD, 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, Melsomar R Ramos, Michael A Charles, Michael D Garcia, Michael D Kawalek, Michael F Schuette, Michael G Mayfield, Michael S Araneta, Michael T Cyrus, Mihaly S Ligmond, Minh D Phan, Monica J Wilkins, Monica R Maxwell, 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, PhD, 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 C Stanton, 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, 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, Sparky L Bartee, Srinivas R Chennamaneni, PhD, Stephanie A Slater, MS, Stephen D Eich, Stephen R Souza, Steven E Porter, Jr, Steven R Ziser, Stuart W Russell, Sudipan Karmakar, Sue Lee Chan, Sumit Sen, Sundy V Sedwick, 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 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, RAC's Documents

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

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