FDA Investigator Paul E Stein

Paul E Stein has conducted inspections on 204 sites in 12 countries as of 17 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
204
Last Inspection Date:
17 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
100005754
Countries of Inspections:
United States of America, United Kingdom of Great Britain and Northern Ireland, Ireland, Germany, Italy, Finland, Netherlands, France, Japan, Denmark, Puerto Rico, Sweden
FDA Investigators that have inspected at least one site in common with Paul E Stein:
Aaron L Dunbar, Abby E Pelletier, Alisha B Patel, Althea A Williams, Amanda Dinaro, Amber D Brodas, Amber D Nair, Amy Wyan Mai, Andrea A Branche, Andrew J Garufi, Anissa M Vargas, Anita Narula, PhD, Ankur C Patel, Ann B Okon, Ann Marie Montemurro, Anna M Alexander, Anthony C Warchut, Arduino Frankovic, Armen H Youssoufian, Arthur F Walker, Arthur G Hurst, Arthur S Williams, Jr, Benjamin J Dastoli, Benjamin W Anderson, Bijoy Panicker, Bill Tacket, Jr, Bo Chi, PhD, Brandy N Lepage, Brian J Ryan, Brian S Keefer, Bryan J Love, Byungja E Marciante, Calvin B Koerner, Carl A Huffman, III, Carl Lee, Carolyn J Cook, Cassandra L Abellard, Catherine J Laufmann, Catherine M Beer, Charisse K Green, Charles N Dupont, Christian Parra, Christine E Kelley, Christopher Janik, Chryste D Best, Claudette D Brooks, Dana A Razzano, Daniel J Lahar, Daniel L Aisen, Daniel T Lee, Daniel W Johnson, Darrell A Collins, Dave M Deroche, David J Gomes, David M Mcnew, David P Vanhouten, David R Delucia, David R Lattuca, Demitria J Argiropoulos, Demitria J Xiradakis, Denise D Dion, Denise L Terzian, Devaughn Edwards, Diamond M Oden, Diane C Thibodeau, Dianiris C Ayala, Dien N Nguyen, Dipesh K Shah, Dolores Harper, Donald C Obenhuber, PhD, Donald G Gordon, Dr. Nallaperumal Chidambaram, Dr. Robert C Horan, MD, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Eduardo L Rodriguez, Edward J Janik, Elizabeth B Griffin, Elizabeth H Davis, Elizabeth H Slazak, Ellen M Landis, Eric S Pittman, Erik Koester, Erin L Nagel, Evelyn Taha, Fatima Bassa, Felix Maldonado, Frank J Marciniak, Frank Wackes, Frederic W French, III, Gam S Zamil, Geoffrey K Kilili, George G Calafactor, George T Allen, Jr, Gregson A Joseph, Harry J Brewer, Helen B Ricalde, Hilary K Wagner, Jacqueline S Warner, James A Liubicich, James L Dunnie, Jr, James W Whitney, Jason A Rossi, Jeanette L Mcginnis, Jeffrey J Thibodeau, Jennifer Lalama, Jesse A Vazquez, Joel R Merriman, Joel R Powers, Joey V Quitania, Jogy George, John A Podsadowski, Jorge L Guadalupe, Joseph J Vannelli, Joseph Milcetic, Juan Rjimenez Garcia, Judy Keihl, Julie Scoma, Justine Tomasso, Karen L Kosar, Karen M Kondas, Karen R Smallwood, Katherine E Jacobitz, Kathryn A Nagy, Kelvin Cheung, Kenneth H Williams, Kent A Conforti, Kevin A Gonzalez, Kim M Downing, Kimberley A Ricketts, Kimberly Lewandowski Walker, Kimberly Y Smithson, Kinh Q Mac, Kwong P Lee, L Gnnmassimia Massimilla, PharmD, Laiza V Garcia, Lata C Mathew, PhD, Laura L Bechard, Lauren E Blaser, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Matthew J Morrison, Leena Thomas, Li Li, Lillie D Witcher, Lirissia Mccoy, Lisa Mathew, Loretta Nemchik, Lori A Carr, Lori S Lawless, LT Luis O Rodriguez, Lydia S Chan, Marc S Neubauer, Marcia D Fields, Marcus F Yambot, Margaret E Sarles, Maribeth G Grattan, Maribeth G Niesen, Marie Elena C Puleo, Marie K Kinkade, Mark E Parmon, Mark R Mcclain, Mary F Finn, Mary M Finn, Maryam Tabatabaie, Matthew A Spataro, Matthew D Schnittker, Maura Rooney, Maya M Davis, Megan A Haggerty, Meghan L Fetterly, Meisha A Mandal, Melissa A Henaghan, Michael A Charles, Michael E Maselli, Michael G Mayfield, Michael G Sinkevich, Michael J Nerz, Michael J Sevka, MD, Michael P Sheehan, Michael P Sweeney, Michael R Dominick, Michael Shanks, MS, Michael W Burd, Michele L Obert, Michelle J Glembin, Mindy M Chou, Mra Davism, Nancy A Saxenian Emmons, Nancy G Schmidt, Neal L Adams, Nicholas C Mendiola, Norman Wong, Nydia E Colon, Paige R Mccoy, Patricia A Clark, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Paul Mouris, Paula A Trost, Pauline N Logan, Perry T Nichols, Peter Abel, Peter M Trunk, Peter R Caparelli, Philip F Istafanos, DMV, MS, Philip H Lafleur, Prabhu P Raju, Preston M Lee, Puspa Suresh Jayasekara, Rachel C Harrington, Rajiv R Srivastava, Ralph Jerndal, Raymond T Oji, Reba A Gates, Regina T Brown, Reyes Candau Chacon, PhD, Richard Jay Tucker, RS, Richard K Glabach, Richard K Vogel, Robert C Coleman, Robert J Veitch, Rodney D Combs, Ronald Ifraimov, Rosanna M Goodrich, Rose Ashley, Roseline N Boateng, Ruben C Quintana, Russ E Davis, Russell J Glapion, Ruth Moore, PhD, Samina S Khan, Samuel K Gibbons, Jr, Samuel T Walker, Sara M Onyango, Sarah A Meehan, Satheesh Thomas, Scott R Izyk, Scott T Ballard, Seema S Singh, Seneca D Toms, Shafiq S Ahadi, Shirley J Berryman, Shreya Shah, Simone E Pitts, Sixto M Mercado Rios, Sony Mathews, Sripal R Mada, PhD, Stephen C Smith, Stephen D Brown, Stephen D Eich, Stephen J Kilker, Stephen R Souza, Steven J Libal, Susan F Laska, MS, Syeda N Mahazabin, Tammy S Notto, Tanya R Syffrard, Tara K Carmody, Thao X Tran, Thomas J Mooney, Tyanna N Hadley, Uduak M Inokon, Unnee Ranjan, Valentino Fiorella, Virgilio F Pacio, CSO, Wanda J Torres, Wayne S Thompson, Wendy M Stone, William C Lubas, William M Rennells, Winston R Alejo, Xiaokuang Lai, PhD, Yehualashet A Gessesse, Yvette Mlacour Davis, Zhong Li, PhD

Paul E Stein's Documents

Publish Date Document Type Title
September, 2003 FDA 483 Instrumentarium Dental, PaloDEx Group Oy - Form 483, 2003-09-04
August, 2009 FDA 483 Blenheim Pharmacal, Inc. - Form 483, 2009-08-17
November, 2001 FDA 483 Arrow International, Inc., Division of Teleflex Medical Inc. - Form 483, 2001-11-30
November, 2001 EIR Arrow International, Inc., Division of Teleflex Medical Inc. - EIR, 2001-11-30
October, 2002 FDA 483 Response Dynarex Corporation - Form 483R, 2002-10-30
March, 2001 EIR Ortho Clinical Diagnostics - EIR, 2001-03-26
November, 2000 FDA 483 Mediware information Systems, Inc. - Form 483, 2000-11-01
September, 2003 EIR Instrumentarium Dental, PaloDEx Group Oy - EIR, 2003-09-04
June, 2000 EIR Medscand Medical Ab - EIR, 2000-06-29
February, 2001 EIR Fidia Farmaceutici, S.p.A. - EIR, 2001-02-02
July, 2001 FDA 483 C.R. Bard Inc. - Form 483, 2001-07-13
October, 2002 FDA 483 Dynarex Corporation - Form 483, 2002-10-22
January, 2012 FDA 483 Barr Laboratories Inc. - Form 483, 2012-01-13
October, 2002 EIR Dynarex Corporation - EIR, 2002-10-22
July, 2005 EIR Curia Global, Inc. - EIR, 2005-07-01
November, 2009 FDA 483 Siemens Healthcare Diagnostics, Inc. - Form 483, 2009-11-24
January, 2003 EIR Hemocare Product Center - EIR, 2003-01-08
September, 2002 EIR Breonics, Inc. - EIR, 2002-09-05
March, 2003 EIR Smiths Medical International Ltd. - EIR, 2003-03-27
January, 2003 FDA 483 Hemocare Product Center - Form 483, 2003-01-08
April, 2003 EIR Isomedix Operations Inc. - EIR, 2003-04-30
January, 2012 EIR Barr Laboratories Inc. - EIR, 2012-01-13
June, 2000 EIR Boston Scientific Limited - EIR, 2000-06-15
July, 2001 EIR C.R. Bard Inc. - EIR, 2001-07-13
September, 2001 FDA 483 Purdue Pharma L.P. - Form 483, 2001-09-21
September, 2001 EIR Purdue Pharma L.P. - EIR, 2001-09-21
April, 2000 FDA 483 Carestream Health, Inc. - Form 483, 2000-04-13
January, 2003 FDA 483 Response Hemocare Product Center - Form 483R, 2003-01-28
December, 2011 FDA 483 Siemens Healthcare Diagnostics, Inc. - Form 483, 2011-12-29

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