FDA Investigator Steven C Madzo

Steven C Madzo has conducted inspections on 39 sites in 16 countries as of 05 Aug 2013. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
39
Last Inspection Date:
05 Aug 2013
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Netherlands, Puerto Rico, United Kingdom of Great Britain and Northern Ireland, United States of America, Poland, Germany, Ireland, Italy, Mexico, France, Switzerland, Japan, Belgium, Portugal, Hungary, Spain
FDA Investigators that have inspected at least one site in common with Steven C Madzo:
Adaliz Santaliz Cruz, Ademola O Daramola, Alan A Rivera, Alice S Tsao, Alicia M Mozzachio, Allison A Aldridge, PhD, Anastasia M Shields, Andrea George, PhD, Andrea J Schmidt, Andrew A Hoopes, Andrew M Kolenc, Ann Marie Montemurro, Anna Lazar, Anthony A Charity, Arlene M Badillo, Arsen Karapetyan, Ashley N Queen, PhD, Azotearc, Barbara Janine Breithaupt, Barbara M Frazier, Bonita S Chester, Brandy N Lepage, Brent W Higgs, Brian D Nicholson, Brooke K Higgins, Bryan A Galvez, Calvin B Koerner, Candace S Tucker, Carla A Norris, Carla Lankford, MD, PhD, Carla R Hinz, Carolyn J Cook, Cary Greene, Caryn M Mcnab, CDR Sean T Creighton, Charles D Brown, Charles I Ann, Charles L Larson, Christine I Shaw, Christopher Downey, PhD, Christopher S Keating, Christopher T Peters, Chryste D Best, Claire M Minden, Colleen Thomas, PhD, Cynthia J Lee, MS, Cynthia Jim, CSO, Daniel J Lahar, Daniel J Roberts, Darla J Christopher, David Frucht, MD, David J Gomes, David L Miser, David M Beltran, Debra L Curtis, Dennis Cantellops Paite, Diane L Raccasi, Don H Bark, PhD, Donald C Obenhuber, PhD, Douglas A Campbell, Douglas C Kovacs, Dov H Pluznik, PhD, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Zhihao Qiu (Peter), PhD, Edith M Gonzalez, Edwin Melendez, Elena Karnaukhova, PhD, Eliezar Ramos, Elisa J Beard, Elvin R Smith, Eric M Mueller, PharmD, Eric S Myskowski, Erika V Butler, Erma Zaimova, Felix J Marrero, Felix Maldonado, Frank W Perrella, George J Flynn, Ginger M Sykes, Gloria A Milster, Grace E Mcnally, Gregory B Ferguson, Gwyn G Dickinson, Hala L Selby, Hanna L Potter, Heika R Tait, Holly L Miller, Isabel Y Espinosa, Ivis L Negron, Jacqueline Mdiaz Albertini, James A Lane, James C Maclaughlin, James D Planchon, James I Giefer, James L Dunnie, Jr, James R Montero, Jamie L Dion, Jason K Morgan, Jennifer A Baker, Jennifer Lalama, Jennifer R Mathern, Jerri Baker, Jessie E Morris, Jianming Li, Joey V Quitania, Jogy George, Jorge L Guadalupe, Jorge L Lajara, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose R Lopez, Jose Velez, Joseph George, Juan A Morales, Justin A Boyd, Kalavati Suvarna, PhD, Katherine E Jacobitz, Katherine Szestypalow, Kathy E Craven, Kathy E Noe, Katie L Penno, Kelly D Moore, Kevin A Gonzalez, Kevin D Kallander, Kham Phommachanh, Kim Lthomas Cruse, Kimberley A Hoefen, Larisa E Pavlick, Larry Gehring, Lauren N Howard, Lauren N Smith, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Ismael Olvera, IV, Leon L Law, Lewis K Antwi, Libia M Lugo, Liming Zhang, Linda M Cheny, Lisa Hornback, LT Rafael Gonzalez, Luella J Rossi, Marc A Jackson, Jr, Marcellinus D Dordunoo, Margaret M Annes, Maria Gutierrez Lugo, PhD, Marian E Ramirez, Marie B Buen Bigornia, Marijo B Kambere, PhD, Marion D Wimberly, Jr, Marion W Nadeau, Marisol Faberlle, Marlene G Swider, Marsha L Mccauley, Martha S Baldwin, Marvin D Jones, Mary F Bodick, Matthew J Sienko, Matthew M Vernon, Matthew R Dionne, Maxwell Van Tassell, PhD, Megan A Haggerty, Melissa J Garcia, Michael A Charles, Michael E Maselli, Michael J Kuchta, Michael L Zimmerman, Michael P Sheehan, Michael R Goga, Michael R Klapal, Michael Shanks, MS, Michele Perry Williams, Michelle Yclark Stuart, Mihaly S Ligmond, Milva E Melendez Perales, Mindy M Chou, Mizanne E Lewis, Monica J Wilkins, Mra B Kamberem, Mra Davism, Mra Mcculloughj, Myriam M Sosa, Nadeem I Chaudhry, Nancy G Schmidt, Nathan R Moon, Nicholas Obiri, PhD, Nicholas R Nance, Nicole A Lloyd, Nicole K Trudel, Nikolay Spiridonov, Noreen Muñiz, Nydia E Colon, Omotunde O Osunsanmi, Pal S Mayasandra, Pankaj H Amin, Patricia A Maestas, Patricia D Leinbach, Patricia D Stahnke, Patricia F Hughes, PhD, Patricia H Dlugosz, Patrick L Wisor, Paul A Bonneau, Paul J Teitell, Paul L Figarole, Jr, Paul Lihong Yeh, PhD, Paul Z Balcer, Paula A Trost, Perry H Gambrell, Philip F Istafanos, DMV, MS, Prabhu P Raju, Pratik S Upadhyay, DDC, Rachel C Harrington, Rafael Padilla, Ralph H Vocque, Ramesh Potla, PhD, Ramon A Hernandez, Randy V Bong, Raymond T Oji, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard E Needham, Richard Heath Coats, Richard L Friedman, Richard W Thornton, Ricki A Chase, Ricky A Crouch, Riley C Myers, PhD, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert Darius, Robert J Martin, Robert M Barbosa, Rodney G Raiford, Roger F Zabinski, Rose Ashley, Rose Xu, Russell J Glapion, Russell K Riley, S Lori Brown, PhD MPH, Samina S Khan, Sandra A Hughes, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Satheesh Thomas, Sharon K Thoma, PharmD, Shelley H Beausoleil, Shererk, Sidney B Priesmeyer, Simone E Pitts, Sixto M Mercado Rios, Sneha S Patel, Stephen D Brown, Steve P Yost, Steven Fong, MS, PhD, Steven M Weinman, Steven O Gauthier, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susanna E Ford, Tajah L Blackburn, Tammara A Stephens, Tara G Bizjak, Tara R Gooen, Teena H Aiken, Terri L Dodds, Thai T Duong, Theressa B Smith, Thomas J Arista, Timothy Wadkin, PhD, Tonnie L Carter, Torrance J Slayton, Verlinda A Narcisse, Vilmary Negron Rodriguez, Walden H Lee, Wayne E Seifert, Wayne T Smith, Wayne W Grundstrom, Wendy G Tan, PhD, Xiomara Copeland, Yasamin Ameri, Zachary L Miller, Zachary L Stamm, Zhong Li, PhD, Zonglin Hu

Steven C Madzo's Documents

Publish Date Document Type Title
January, 2010 FDA 483 Nelson Laboratories, LLC - Form 483, 2010-01-08
March, 2009 FDA 483 Response Golden Boy Foods, Ldt. - Form 483R, 2009-04-10
March, 2012 EIR Nelson Laboratories, LLC - EIR, 2012-03-09
March, 2004 FDA 483 HIKMA FARMACEUTICA (PORTUGAL), S.A - Form 483, 2004-03-31
March, 2013 FDA 483 Response Amgen, Inc. - Form 483R, 2013-08-07
May, 2001 EIR AlloSource - EIR, 2001-05-02
July, 2013 FDA 483 ACS DOBFAR SPA - Form 483, 2013-07-04
March, 2009 FDA 483 Golden Boy Foods, Ldt. - Form 483, 2009-03-10
May, 2002 FDA 483 Response ACS DOBFAR SPA - Form 483R, 2002-08-06
May, 2002 EIR ACS DOBFAR SPA - EIR, 2002-06-02
March, 2013 EIR Amgen, Incorporated - EIR, 2013-03-29
May, 2002 EIR ACS DOBFAR SPA - EIR, 2005-06-02
May, 2007 EIR Teva Pharmaceuticals Works Private Limited Company - EIR, 2007-05-31
December, 2001 FDA 483 Nelson Laboratories, LLC - Form 483, 2001-12-19
March, 2013 FDA 483 Amgen, Incorporated - Form 483, 2013-03-29
March, 2013 EIR Amgen, Inc. - EIR, 2013-03-29
May, 2002 FDA 483 ACS DOBFAR SPA - Form 483, 2002-05-29
December, 2001 EIR Nelson Laboratories, LLC - EIR, 2001-12-19
May, 2002 FDA 483 ACS DOBFAR SPA - Form 483, 2002-05-21
May, 2009 EIR N.V. Organon - EIR, 2009-05-14
May, 2002 FDA 483 Response ACS DOBFAR SPA - Form 483R, 2002-07-29
May, 2002 EIR ACS DOBFAR SPA - EIR, 2002-06-02
May, 2002 FDA 483 ACS DOBFAR SPA - Form 483, 2002-05-31
November, 2012 EIR Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) - EIR, 2012-11-09
March, 2009 EIR Golden Boy Foods, Ldt. - EIR, 2009-03-10
February, 2002 FDA 483 GE Healthcare Ireland Limited - Form 483, 2002-02-12
November, 2012 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) - Form 483, 2012-11-09
May, 2002 FDA 483 Response ACS DOBFAR SPA - Form 483R, 2003-03-14
March, 2013 FDA 483 Amgen, Inc. - Form 483, 2013-03-29
March, 2012 FDA 483 Nelson Laboratories, LLC - Form 483, 2012-03-09

Experience Redica Systems’ 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