FDA Investigator Jeffrey A Sommers

Jeffrey A Sommers has conducted inspections on 86 sites in 11 countries as of 20 Mar 2005. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
86
Last Inspection Date:
20 Mar 2005
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Spain, United States of America, Germany, Japan, Hungary, France, United Kingdom of Great Britain and Northern Ireland, Ireland, Israel, Romania, Sweden
FDA Investigators that have inspected at least one site in common with Jeffrey A Sommers:
Alexandra A Carrico, Amanda L Baskin, Anastasia M Shields, Andrace L Deyampert, Andre S Raw, Andrea D Swingle, Andrew J Barrowcliff, Anna Lazar, Anthony C Warchut, Antonio M Hampton, Art O Czabaniuk, Ava M Bowman, Azza Talaat, Barbara D Bennett, Bei Y He, Benjamin J Smith, Bijoy Panicker, Bo Chi, PhD, Bogdan Kurtyka, Brandi N Mcgrady, Brentley S Collins, Brian M Campbell, Brooke K Higgins, Brooke K Seeman, Burnell M Henry, Byungja E Marciante, Calvin K Cook, Carla J Lundi, Caroline H Le, Catherine V Quinlan, CDR Ileana Barreto Pettit, CDR Kimberly Y Martin, Charisse K Green, Charles I Ann, Charles L Zhou, Charles M Edwards, Charles M Spyr, Cheng H Yen, Cheryl A Clausen, Christian D Lynch (CDL), Christine W Twohy, Colleen Thomas, PhD, Constantin Y Philopoulos, Corrine M Carter, Cynthia J Lee, MS, Danial S Hutchison, Daniel J Brown, Daniel J Gorski, Darla J Christopher, Darren S Morgan, David A Paterson, David J Gasparovich, David K Glasgow, Dawn C Olenjack, Debara R Reese, Debara Reese, Delaram Moshkelani, Demitria J Xiradakis, Denise L Burosh, Dennis E Guilfoyle, PhD, Dennis R Downer, Dina A Tallman, Don H Bark, PhD, Donald C Obenhuber, PhD, Douglas A Campbell, Douglas C Kovacs, Eboni S Funderburk, Eliezar Ramos, Emest F Bizjak, Emilie E Kahn, Emily J Orban, Enrico Joset Mangahis, Eric S Pittman, Erika V Butler, Francis A Guidry, Frederick F Razzaghi, Gary Durbiel Goldner, Gene D Arcy, Geneve M Maxwell, Geneve M Parks, George G Calafactor, Geraldine D Sanders, Ginger M Sykes, Hans T Meyers, Helen B Ricalde, Heriberto Negron Rivera, Howard Anderson, PhD, Ifueko Osemwota, Jacob G Lutz, Jacqueline Mdiaz Albertini, Jagan Mohanr Parepally, PhD, James I Giefer, James K Ireland, James L Dunnie, Jr, James P Mcevoy, James P Stumpff, Janet L Bowen, Javier E Santos, Jazmine N Still, Jean Blackston Hill, Jeffrey D Meng, Jennifer A Kemp, Jennifer D Hollstrom, Jennifer L Schmidt, Jennifer R Johnson, Joey V Quitania, John D White, John N Woodall, John P Mistler, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose R Hernandez, Joseph A Piechocki, Joseph R Strelnik, Joshua P Wireman, Julie D Bringger, Justin A Boyd, Karen E D'orazio, Karen L Kosar, Karen M Montgomery (KMM), Kathryn G Brown, Kham Phommachanh, Kip J Hanks, L'oreal F Walker, Lakshmi Narasimhan, PhD, Larry K Austin, Lauren E Sexton, Lauren Iacono Connors, PhD, Laurie B Frazier, Laurimer Kuilan Torres, Leigh Anne Myers, Leonard H Lavi, Leslie A Paul, Liatte Kreuger, PharmD, Libia M Lugo, Linda S Jozefiak, Lindsey M Schwierjohann, Lisa L Flores, Lisa M Bellows, Logan T Williams, Lourdes Valentin Aponte, Luella J Rossi, Makini Cobourne Duval, PhD, Maria Gutierrez Lugo, PhD, Mark R Mcclain, Martha Sullivan Myrick, Matt D Suedkamp, Matthew B Casale, Matthew J Gretkierewicz, Meisha R Sampson, Meisha Waters, Melina Lrodriguez Upton, Melissa J Garcia, Mercy Oyugi, Michael A Charles, Michael E Maselli, Michael G Truchan, Michael L Chasey, Michael P Sheehan, Michael Shanks, MS, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Miguel A Martinez Perez, Mihaly S Ligmond, Montgomery Montgomery, Karen M, Mra B Kamberem, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Muna Algharibeh, Myra K Casey, Nadeem I Chaudhry, Nailing Zhang, Nancy G Schmidt, Natalie A Mickelsen, DVM, Neal D Singletary, PhD, Neal L Adams, Neali H Lucas, Nicholas L Paulin, Pal S Mayasandra, Paranthaman Senthamaraikannan, Patricia A Cochran, Patricia H Dlugosz, Patrick B Cummings, Patrick C Klotzbuecher, Patsy J Domingo, Paul A Bonneau, Paul L Bellamy, Paula A Trost, Peng Zhou, Philip A Klimkewicz, Prabhu P Raju, Qiao Y Bobo, Rafeeq A Habeeb, Rajiv R Srivastava, Ralph A Erickson, Raymond R Roy, PhD, Raymond T Oji, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Rodriguez, Richard E Needham, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert J Ham, Robert J Martin, Robert M Barbosa, Robert R Barbosa, Rochelle K Kimmel, Roger F Zabinski, Rohn R Robertson, Ronald G Crawford, Rose Ashley, Rose Xu, Rumany C Penn, PharmD, Russell J Glapion, S Lori Brown, PhD MPH, Saleem A Akhtar, Samantha J Bradley, Samuel H Chan, PharmD, Sandra A Boyd, Sanket N Patel, Sara M Onyango, Sarah B Tanksley, Sarah E Rhoades, Sarah M Meng, Sarah M Napier, Sarah Rhoades, Satheesh Thomas, Scott A Golladay, Scott T Ballard, Sharon K Thoma, PharmD, Shawn E Larson, Simone E Pitts, Sixto M Mercado Rios, Sonia R Peterson, Sri Ramakrishnaiah Yellela, PhD, Stephen J Mottola, Stephen R Souza, Steven A Gonzales, Steven E Bowen, PhD, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susanna E Ford, Suyang Qin, Tara R Gooen, Temar Q Williams, Thomas A Peter, Thomas J Arista, Thomas J Cosgrove, Thuy T Nguyen, LCDR, Tiffani D Wilson, Timothy T Kapsala, Tina M Pawlowski, Tonia F Bernard, Tonnie L Carter, Tonya R Johnson, Torrance J Slayton, Tracey Asinjen Wiersma, Tracey L Harris, Tracey L Siebesma, Travis V Hull, Ucheabuchi Cchudi Nwankwor, Vera M Anderson, Vilmary Negron Rodriguez, Vlada Matusovsky, Wayne E Seifert, Wenzheng Wendy Zhang, William A Warnick, William D Tingley, Xikui Chen (nmi), PhD, Yangmin Ning, Yiwei Li, Yiyue Zhang (nmi), PhD, Yumi J Hiramine, Zachary L Miller, Zhenzhen Liu, PhD

Jeffrey A Sommers's Documents

Publish Date Document Type Title
March, 2005 FDA 483 Assia Chemical Industries Ltd. - Teva Tech Site - Form 483, 2005-03-23
October, 2004 EIR Euticals Ltd. - EIR, 2004-12-10
May, 2001 FDA 483 Martin Ekwealor Pharmaceuticals, Inc. - Form 483, 2001-05-03
December, 2000 FDA 483 Elanco Clinton Laboratories - Form 483, 2000-12-08
May, 2003 EIR Eli Lilly and Company - EIR, 2003-05-29
September, 2000 FDA 483 Response Cambrex Karlskoga AB - Form 483R, 2000-10-10
March, 2003 FDA 483 Exelead, Inc. - Form 483, 2003-03-10
March, 2001 EIR Bayer Weimar GmbH und Co. KG - EIR, 2001-05-15
March, 2004 EIR Applied Laboratories, Inc. - EIR, 2004-03-26
January, 2002 FDA 483 Eli Lilly and Company - Form 483, 2002-01-11
February, 2002 FDA 483 Martin Ekwealor Pharmaceuticals, Inc. - Form 483, 2002-02-13
March, 2003 FDA 483 Response Exelead, Inc. - Form 483R, 2003-04-02
July, 2004 FDA 483 Baxter Pharmaceutical Solutions LLC - Form 483, 2004-07-01
October, 2001 FDA 483 Response PD Pharmatech, LLC. - Form 483R, 2001-10-23
September, 2000 FDA 483 Cambrex Karlskoga AB - Form 483, 2000-09-27
July, 2001 FDA 483 Vesta Pharmaceuticals, Inc. - Form 483, 2001-07-17
January, 2001 FDA 483 Response Pfizer Inc - Form 483R, 2001-02-12
April, 2002 EIR Evonik Corporation - EIR, 2002-04-18
January, 2001 EIR Pfizer Inc - EIR, 2001-01-23
May, 2003 FDA 483 Eli Lilly and Company - Form 483, 2003-05-29
September, 2000 EIR Cambrex Karlskoga AB - EIR, 2000-09-27
April, 2000 FDA 483 Response Vesta Pharmaceuticals, Inc. - Form 483R, 2000-04-21
December, 2003 FDA 483 Vesta Pharmaceuticals, Inc. - Form 483, 2003-12-19
January, 2002 FDA 483 Response Eli Lilly and Company - Form 483R, 2002-01-25
April, 2004 EIR Exelead, Inc. - EIR, 2004-04-21
August, 2004 FDA 483 Century Pharmaceuticals, Inc. - Form 483, 2004-08-26
October, 2001 FDA 483 PD Pharmatech, LLC. - Form 483, 2001-10-15
December, 2001 FDA 483 Pfizer Inc - Form 483, 2001-12-06
February, 2000 FDA 483 Meiji Seika Pharma Co., Ltd. - Form 483, 2000-02-23
March, 2005 EIR Assia Chemical Industries Ltd. - Teva Tech Site - EIR, 2005-03-23
January, 2003 FDA 483 PD Pharmatech, LLC. - Form 483, 2003-01-30
January, 2001 FDA 483 Pfizer Inc - Form 483, 2001-01-23
December, 2001 FDA 483 Response Pfizer Inc - Form 483R, 2001-12-21
September, 2003 EIR Lannett Company, Inc. - EIR, 2003-09-09
April, 2000 FDA 483 Vesta Pharmaceuticals, Inc. - Form 483, 2000-04-12
May, 2002 FDA 483 Earlham Analytical Laboratory - Form 483, 2002-05-31
April, 2002 FDA 483 Response Evonik Corporation - Form 483R, 2002-05-02
July, 2001 EIR Vesta Pharmaceuticals, Inc. - EIR, 2001-07-17
February, 2001 FDA 483 Eli Lilly and Company - Form 483, 2001-02-23
February, 2001 FDA 483 Response Eli Lilly and Company - Form 483R, 2001-03-08
March, 2003 EIR Exelead, Inc. - EIR, 2003-03-10
April, 2000 EIR Vesta Pharmaceuticals, Inc. - EIR, 2000-04-12
October, 2001 EIR PD Pharmatech, LLC. - EIR, 2001-10-15
January, 2005 FDA 483 Martin Ekwealor Pharmaceuticals, Inc. - Form 483, 2005-01-18
April, 2004 FDA 483 Exelead, Inc. - Form 483, 2004-04-21
September, 2000 FDA 483 Bayer AG - Form 483, 2000-09-22
June, 2000 EIR Pharmacia & Upjohn Company LLC - EIR, 2000-06-28
December, 2000 EIR Elanco Clinton Laboratories - EIR, 2000-12-08
June, 2000 FDA 483 Pharmacia & Upjohn Company LLC - Form 483, 2000-06-28
April, 2003 EIR Pfizer Inc - EIR, 2003-04-25
October, 2004 FDA 483 Response Euticals Ltd. - Form 483R, 2004-11-08
August, 2003 FDA 483 Century Pharmaceuticals, Inc. - Form 483, 2003-08-07
May, 2002 EIR Earlham Analytical Laboratory - EIR, 2002-05-31
July, 2000 EIR Eli Lilly and Company - EIR, 2000-07-10
March, 2004 FDA 483 Applied Laboratories, Inc. - Form 483, 2004-03-26
January, 2002 EIR Eli Lilly and Company - EIR, 2002-01-11
March, 2004 FDA 483 Response Applied Laboratories, Inc. - Form 483R, 2004-04-19
October, 2004 FDA 483 Clariant Life Science Molecules (UK), Ltd. - Form 483, 2004-10-19
September, 2000 EIR Bayer AG - EIR, 2000-11-02
October, 2003 EIR Elanco Clinton Laboratories - EIR, 2003-10-31
April, 2004 FDA 483 Response Exelead, Inc. - Form 483R, 2004-05-21
July, 2002 FDA 483 Response SK BIOTEK IRELAND LIMITED - Form 483R, 2002-10-01
April, 2002 FDA 483 Evonik Corporation - Form 483, 2002-04-18
June, 2000 FDA 483 Response Pharmacia & Upjohn Company LLC - Form 483R, 2000-07-14
October, 2002 FDA 483 Response Lannett Company, Inc. - Form 483R, 2002-10-28
October, 2002 FDA 483 Lannett Company, Inc. - Form 483, 2002-10-18
February, 2000 EIR Meiji Seika Pharma Co., Ltd. - EIR, 2000-03-10
December, 2000 FDA 483 Response Elanco Clinton Laboratories - Form 483R, 2000-12-20
March, 2002 FDA 483 Pfizer Inc - Form 483, 2002-03-01
October, 2002 EIR Lannett Company, Inc. - EIR, 2002-10-18
March, 2001 FDA 483 Schering GmbH - Form 483, 2001-03-22
December, 2001 EIR Pfizer Inc - EIR, 2001-12-06
March, 2001 FDA 483 Response Bayer Weimar GmbH und Co. KG - Form 483R, 2001-04-03
January, 2002 EIR Eli Lilly and Company - EIR, 2002-01-14

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