FDA Investigator Stephen C Smith

Stephen C Smith has inspections in 18 countries as of 15 Sep 2023. Stephen C Smith has collaborated with a combinined 5146 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
231
Last Inspection Date:
15 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
100009052
Country:
China, United States of America, United Kingdom of Great Britain and Northern Ireland, Australia, Germany, Mexico, France, Malaysia, Japan, Canada, Uruguay, Netherlands, Taiwan, Thailand, Dominican Republic, Spain, Ireland
Co-Investigator(s):
A Williams, Abby E Pelletier, Aditi S Thakur, Alan M Stevens, Alice C Silva, Allison A Rodriguez, Alysia M Salonia, Amber G Wardwell, Andre S Lamontagne, Andrew P Abban, Angel Asoler Garcia, Anita Narula, PhD, Ann Marie Montemurro, Anthony N Onianwa, Anthony P Costello, Anthony W Thomas, Arduino Frankovic, Arie C Menachem, Arthur S Williams, Jr, Ashley M Whitehurst, Benjamin W Anderson, Bo Chi, PhD, Brenda P King, Brian S Keefer, Byungja E Marciante, Calvin B Koerner, Camerson E Moore, Carla C Tuite, Casey L Hamblin, Catherine J Laufmann, Charles L Larson, Charles N Dupont, Charles R Clavet, Christine L Williams, Christine M Parmentier, Christopher A Demitrius, Christopher J Cruciotti, Chunchun Zhang, Claudette D Brooks, Clotia Cabbey Mensah, Connie L Hannon Rabel, Creighton T Tuzon, Crystal Nevins, Daniel J Lahar, Daniel L Zheng, Darin S Wiegers, Daryl A Dewoskin, David C Sullivan, David J Feria, David J Gomes, David P Vanhouten, Dawn Hraswell, Dawn M Braswell, Diane C Thibodeau, Diane M Biron, Dien N Nguyen, Dominic R Frasca, Donald C Obenhuber, PhD, Dorothy W Lee, Edmund F Mrak, Jr, Edward D Mcdonald, Edward J Janik, Eileen T Maher, Elizabeth B Griffin, Elkins, Ellen P Madigan, Elmiloudi M Sarhrani, Emir Galevi, Eric C Schmitt, Erich P Garger, Erik W Koester, Esteban Beltran, Evelyn Taha, Felix J Marrero, Frank J Koch, Frank J Marciniak, Frank P Hurst, Frederic W French, III, Gale E Ryan, Garry H Stewart, Gary J Hagan, George T Allen, Jr, Gerard D Difiore, Gregson A Joseph, Guozhou Mo, H Ljamilla Selby, Hala L Selby, Harperd, Helen B Ricalde, Hien Albright, Holly S Simms, Iris C Macinnes, Jacqueline S Warner, James H Tanner, James L Dunnie, Jr, James P Finn, James P Mcreavey, James R Montero, James W Plucinski, James W Whitney, Jamie S Mathews, Janet B Abt, Janet Pulver, Janete F Guardia, Jason A Rossi, Jason B Prosser, Jayaleka J Amarasinghe, Jeffrey J Thibodeau, Jeffrey S Buckser, Jessica D Spellman, Joann F Fujikawa, Joey C West, Joey V Quitania, John A Sciacchitano, John L Zaccone, John P Mistler, John P Shelton, John R Carlson, John S Hartford, Jonathan B Lewis, Jonathan G Matrisciano, Joppie, Jose R Hernandez, Joseph B Cascio, Joseph C Teixeira, Joseph T Frost, Joshua L Gibbs, Joyce A Kellett, Justine M Corson, Justine Tomasso, Karen A Coleman, Karen L Kosar, Karen M Rodriguez, Karen Mcnabb Noon, Katarzyna Plona, Kathleen E Mcafoose, Kelvin Cheung, Kent A Conforti, Kim M Downing, Kimberly Lewandowski Walker, Kwong P Lee, Laiza V Garcia, Lauren M Lawrance, Laurie B Frazier, LCDR Debra Emerson, Leanna M Slarsky, Leighton K Ngai, Leonard H Lavi, Lisa D Cash, Liz M Otero, Louis Christy, Lydia S Chan, Lyndsay M Perryman, Lynne M Dwyer, M Patriciaurphy Murphy, Maida Henesian (NMI), Marcia M Laughrey, Marcus F Yambot, Margaret E Walsh, Margaret M Sands, Mark E Chan, Mark R Mcclain, Marlo Ianm Alintanahin, Martin J Guardia, Mary A Millner, Mary Jeanet Mcgarry, Maryam Tabatabaie, Matthew B Hazelett, Matthew C Watson, Matthew D Schnittker, Matthew D Silverman, Matthew W Kyle, Maura Rooney, Maureen L Dreher, Maya M Davis, Megan A Haggerty, Mei Chen Mu, Michael E Maselli, Michael G Mayfield, Michael P Anthony, Michael P Sweeney, Michael R Goga, Michael Serrano, Michael Shanks, MS, Michele L Obert, Michelle J Glembin, Michelle L Johnson, Michelle M Noe, Monique C Lo, Mra Davism, Msdap Gonzlezk, Mutahar S Shamsi, Nabil Nakhoul, Nancy L Neiger, Nassim Ben Makhlouf, Neal L Adams, Nealie C Newberger, Nichole B Murphy, Osama A Khatib, Pamela L Ogonowski, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul E Stein, Paul M Gelfand, Paul P Geraci, Paula A Trost, Paula M Laplant, Pauline N Logan, Perry H Gambrell, Philip H Lafleur, Prabhu P Raju, Preston M Lee, Quynh H Strandberg, Rafael Padilla, Ralph Jerndal, Ramcharan S Khalsa, Ramon E Martinez, Rebecca B Welch, Regina T Brown, Reyes Candau Chacon, PhD, Richard F Hapke, Richard Jay Tucker, RS, Richard K Vogel, Richard L Licari, Richard L Rutherford, Robert C Coleman, Robert G Ruff, Robert J Martin, Rodney D Combs, Ronald T Weber, Rory K Geyer, Rosanna M Goodrich, Rose M Ashley, Roy Baby, Rupa Pradhan, Ruth Moore, PhD, Ryan J Mcgowan, Samuel K Gibbons, Jr, Sandra P White, Sara M Onyango, Sara M Richardson, Sargum C Sood, Scott B Laufenberg, Scott M Loughan, Sean R Marcsisin, Seneca D Toms, Sergio Chavez (NMI), Seth A Mailhot, Shaquenta Y Perkins, Shawn M Bogdan, Sherry K Markwell, Sherry M Nisson, Shirley J Berryman, Slater K Bartlett, Stacey S Degarmo, State Agency, Stefan Kaszycki, Stephen C King, Stephen D Brown, Stephen D Eich, Stephen R Souza, Steven M Ferrara, Steven R Ziser, Sunita Pandey, Susan F Laska, MS, Susanne M Richardson, MSc RAC ELS, Suzanne M Healy, Tamara M Kays, Tamara S Rosbury, Tania E Vizcaino, Teddy Tom, Teresa Jimenez, Terry C Kimball, Thai T Duong, Theresa M To, Thomas B Gilmore, Tina A Desorcy, Todd J Maushart, Troy R Petrillo, Tuan A Nguyen, Victor Spanioli, Vidya B Pai, Virgilio F Pacio, CSO, Vivian Garcia, Wendy A Johnecheck, William K Dagley, Xiaojun Yan, Xiaokuang Lai, PhD, Yaodong Huang, Yehualashet A Gessesse, Yumi J Hiramine, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zonglin Hu

Stephen C Smith's Documents

Publish Date Document Type Title
November, 2018 FDA 483 Anuncia, Inc. - Form 483, 2018-11-14
October, 2019 FDA 483 ATC Technologies, Inc. - Form 483, 2019-10-07
December, 2019 FDA 483 DIMA S.L. - Form 483, 2019-12-19
August, 2017 FDA 483 Foresight Imaging, LLC - Form 483, 2017-08-29
August, 2020 FDA 483 Benchmark Electronics, Inc. - Form 483, 2020-08-26
December, 2015 FDA 483 Dartmouth Hitchcock Medical Center - Form 483, 2015-12-29
December, 2015 EIR BRIGHAM AND WOMEN`S HOSPITAL, INC., THE - EIR, 2015-12-10
September, 2017 FDA 483 GeoTec, Inc. - Form 483, 2017-09-29
July, 2017 EIR Biotechne, Inc. - EIR, 2017-07-20
March, 2014 EIR NYPRO Finpack Clinton - EIR, 2014-03-21
December, 2019 FDA 483 Exmoor Plastics Ltd. - Form 483, 2019-12-05
January, 2018 FDA 483 Fresenius Medical Care Holdings, Inc. - Form 483, 2018-01-12
September, 2013 EIR Health & Life (Suzhou) Co., Ltd. - EIR, 2013-09-18
April, 2019 FDA 483 InfoBionic, Inc. - Form 483, 2019-04-10
November, 2018 EIR Anuncia, Inc. - EIR, 2018-11-14
September, 2016 FDA 483 Data Innovations, LLC - Form 483, 2016-09-05
November, 2015 FDA 483 XuZhou Kernel Medical Instrument Equipment Co. Ltd - Form 483, 2015-11-12
July, 2019 FDA 483 Gauss Surgical, Inc. - Form 483, 2019-07-18
November, 2015 EIR XuZhou Kernel Medical Instrument Equipment Co. Ltd - EIR, 2015-11-12
March, 2017 FDA 483 Response Spectra Medical Devices, LLC - Form 483R, 2017-04-14
February, 2016 FDA 483 Neurotherm LLC - Form 483, 2016-02-04
August, 2012 FDA 483 Razel Scientific Instruments, Inc. - Form 483, 2012-08-02
August, 2018 FDA 483 Atrium Medical Corporation - Form 483, 2018-08-02
August, 2020 EIR Benchmark Electronics, Inc. - EIR, 2020-10-08
December, 2011 FDA 483 Changshu Excellent Medical Products Co., Ltd. - Form 483, 2011-12-01
March, 2016 FDA 483 Vtech Communications Ltd. - Form 483, 2016-03-24
March, 2015 FDA 483 Insulet Corporation - Form 483, 2015-03-27
September, 2017 FDA 483 Banyan Medical, LLC - Form 483, 2017-09-29
February, 2022 FDA 483 Evoqua Water Technologies, LLC - Form 483, 2022-02-24
March, 2016 EIR Vtech Communications Ltd. - EIR, 2016-03-24
July, 2021 FDA 483 CooperSurgical, Inc. - Form 483, 2021-07-15
February, 2020 FDA 483 Breas Medical, Inc. - Form 483, 2020-02-06
March, 2017 EIR Spectra Medical Devices, LLC - EIR, 2017-03-30
January, 2018 FDA 483 Provent Sleep Therapy LLC - Form 483, 2018-01-03
July, 2015 FDA 483 Allergan Medical - Form 483, 2015-07-07
February, 2023 FDA 483 SoClean, Inc - Form 483, 2023-02-06
October, 2011 EIR Isomedix Operations Inc - EIR, 2011-10-19
February, 2023 FDA 483 AADCO Medical Inc. - Form 483, 2023-02-22
March, 2017 FDA 483 Nypro Clinton - Form 483, 2017-03-17
April, 2014 FDA 483 Meifu Medical Technology Suzhou Co. Ltd. - Form 483, 2014-04-10
June, 2018 FDA 483 Catalent Massachusetts, LLC - Form 483, 2018-06-18
December, 2016 EIR Karl Storz Endovision, Inc. - EIR, 2016-12-20
March, 2014 FDA 483 NYPRO Finpack Clinton - Form 483, 2014-03-21
June, 2016 FDA 483 Implant Dental Technology Co., Ltd. - Form 483, 2016-06-30
December, 2015 FDA 483 Response BRIGHAM AND WOMEN`S HOSPITAL, INC., THE - Form 483R, 2016-01-04
April, 2011 FDA 483 A-T Surgical Company, LLC - Form 483, 2011-04-13
March, 2012 FDA 483 Becton Dickinson Medical Systems - Form 483, 2012-03-16
April, 2013 FDA 483 Bescon Co., Ltd. - Form 483, 2013-04-11
April, 2015 FDA 483 Olympus Medical Systems Corporation - Form 483, 2015-04-24
February, 2014 FDA 483 Surgical Tables Incorporated - Form 483, 2014-02-06
April, 2019 FDA 483 Elucid Bioimaging Inc. - Form 483, 2019-04-03
April, 2017 FDA 483 RESEARCH INSTRUMENTS LTD - SITE B - Form 483, 2017-04-13
October, 2013 FDA 483 Atrium Medical Corporation - Form 483, 2013-10-01
March, 2013 FDA 483 Remote Technologies, Inc. - Form 483, 2013-03-13
April, 2015 EIR Olympus Medical Systems Corporation - EIR, 2015-04-24
September, 2012 FDA 483 Aus Systems Pty Ltd - Form 483, 2012-09-12
April, 2014 FDA 483 Hu-Friedy Medical Instrument (Shanghai) Co. Ltd. - Form 483, 2014-04-18
December, 2015 FDA 483 BRIGHAM AND WOMEN`S HOSPITAL, INC., THE - Form 483, 2015-12-29
December, 2019 FDA 483 Future Diagnostics Solutions B.V. - Form 483, 2019-12-12
October, 2014 FDA 483 EMG Technology Co., Ltd. - Form 483, 2014-10-23
June, 2016 FDA 483 TIANJIN SEASON TECHNOLOGY CO., LTD - Form 483, 2016-06-23
October, 2022 FDA 483 Teledyne Flir Commercial Systems, Inc. - Form 483, 2022-10-04
November, 2021 FDA 483 TEI Biosciences, Inc. - Form 483, 2021-11-12
March, 2015 FDA 483 Response Insulet Corporation - Form 483R, 2015-04-16
August, 2021 FDA 483 Henke Sass Wolf Of America,Inc - Form 483, 2021-08-11
August, 2012 FDA 483 Guidewire Technologies, Inc. - Form 483, 2012-08-16
April, 2015 FDA 483 Aizu Olympus Co., Ltd. - Form 483, 2015-04-17
February, 2017 FDA 483 Candela Corporation - Form 483, 2017-03-08
August, 2009 FDA 483 Smith & Nephew Inc. - Form 483, 2009-08-06
May, 2010 FDA 483 Aurora Healthcare US Corp - Form 483, 2010-05-07
August, 2022 FDA 483 Centro de Construccion de Cardioestimuladores del Uruguay SA - Form 483, 2022-08-18
February, 2019 FDA 483 Hitachi High-Technologies Corp., Omuta Center - Form 483, 2019-02-28

Experience Redica System's NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more