FDA Investigator Jennifer M Gogley

Jennifer M Gogley has conducted inspections on 94 sites in 12 countries as of 12 Nov 2019. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
94
Last Inspection Date:
12 Nov 2019
Investigator Role:
FDA Investigator
Redica ID:
100006288
Countries of Inspections:
United States of America, Switzerland, Italy, Australia, Singapore, Sweden, Germany, Austria, Korea (Republic of), United Kingdom of Great Britain and Northern Ireland, Brazil, Ireland
FDA Investigators that have inspected at least one site in common with Jennifer M Gogley:
Aaron J Adler, Adam R Cooke, Alan L Truong, Alan P Kurtzberg, Alexandra B Pitkin, Alexandria L Capuano, Allen F Hall, Allison A Rodriguez, Althea A Williams, Amalia C Himaya, Amanda L Fyles, Amir Alavi, Anastasia M Shields, Anderson, Andrea A Branche, Andrew J Barrowcliff, Andrew K Haack, PhD, Andrew S Limson, Angela E Glenn, Angela Shepas, Angele C Smith, Anita Narula, PhD, Anjali Shukla, PhD, Ann L Demarco, Anthony G Emerson, April C Inyard, April P Shaw, Arie C Menachem, Arsen Karapetyan, Ashar P Parikh, Ashley N Queen, PhD, Azza Talaat, Babajide Michael Osunsanmi, Barbara J Rincon, Barry Cherney, PhD, Bazarragchaa Damdinsuren, PhD, Benjamin J Dastoli, Bichsa T Tran, Binh T Nguyen, Bo Chi, PhD, Bonnie I Needleman, Brenda W Uratani, PhD, Brian J Ryan, Brian P Putz, Brien C Fox, Bruce H Mccullough, Bryan A Galvez, Calvin B Koerner, Carl A Huffman, III, Carla J Lundi, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Cathleen A Carr Sharpe, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Cecilia H Kieu, Celena Ngo, Charisse K Green, Charles I Ann, Charles L Larson, Chelsea N Sealey, Cheron M Portee, Christina C Santos, Christina Capacci Daniel, PhD, Christina V Santos, Christine W Twohy, Christopher D Washington, Christopher R Czajka, Claire M Minden, Claudia Mperez Kasmarski, Comyar Shoghi, Corey K Reno, Crystal Monroy, Cynthia Jim, CSO, Cynthia L Gorveatt, Daniel R Solis, Daniel W Cline, Darren S Brown, David G Whitman, David M Beltran, David Serrano, Davinna Ligons, PhD, Deborah A Greco, Deborah Schmiel, PhD, Dejon N Harris, Dennis Cantellops Paite, Diane Cvan Leeuwen, Diane L Raccasi, Diane R Weidley, Djamila Harouaka, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Dolores Harper, Don H Bark, PhD, Donald H Barks, Donna Ltartaglino Besone, Donna Mwilliams Hill, PhD, Douglas A Campbell, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Zhihao Qiu (Peter), PhD, Drew M Love, Dyana K Stone, Edmund F Mrak, Jr, Edwin Melendez, Eileen A Liu, Elaine A Bunch, Elizabeth A Brown, Elizabeth Ad Girard, Emilie E Kahn, Erika V Butler, Esther C Broner, PhD, Evelyn Wong, Frances Namuswe, PhD, Francis A Guidry, Francisco, Frederick L Fricke, Gene D Arcy, George R Smith, Gilbert T Salud, Grace Deneke, Grace P Santos, Greg K Keshishyan, Gregory A Berg, Gwyn G Dickinson, Haley H Seymour, Haoheng Yan, PhD, Haroon Vohra (NMI), Hasan A Irier, PhD, Heidy C Perales, Helen B Ricalde, Himanshu Gupta, PhD, Homero W Aguilar, Hossein Khorshidi, PhD, Iris C Macinnes, Jacob G Lutz, James A Barreto, James B Arnett, James C Maclaughlin, James I Giefer, James L Dunnie, Jr, James P Stumpff, James R Fleckenstein, Jamie M Du, Jane S Wernberg, Janet D Blount, Janet Pulver, Jasmine N Thompson, Jee Chung, PhD, Jeffery A Johnson, Jeffrey P Raimondi, Jennifer Gogley, Jennifer L Huntington, Jeremy Beber, Jeremy H Nguyen, Jinnie Kokiatkulkij, Joan A Loreng, Joan M Cantellops Figueroa, Jocelyn E Massey, Jocelyn E Sparks, Joe X Phillips, Joel D Hustedt, Joel Welch, PhD, Joey V Quitania, John A Gonzalez, John L Stevens, John R Myung, Jolanna A Norton, Jose Acruz Gonzalez, Jose M Cayuela, Jose M Melendez, Jose R Hernandez, Joseph C Yen, Joseph X Phillips, Juanita Banuelos, Judy C Nepsa, Julia Ventura, Julie A Rorberg, Julie A Stocklin, Junho Pak, Ka L Wong, Karen L Bauer, Kari M Johansen, Katherine E Jacobitz, Kathleen R Jones, PhD, Kathy Chiu, Kathy Kuo, Keith P Iams, Kelley, Kellia N Hicks, Kelvin Cheung, Kelvin X Sanders, Kendra A Biddick, Kenneth M Gordon, Kevin D Kallander, Kevin T Gerrity, Kham Phommachanh, Khoa Nathanv Tran, Kim Lthomas Cruse, Kimberly M Lichter, Kirtida Patel, Kristen D Evans, Kristin M Abaonza, Kumar G Janoria, Lakecha N Lewis, Lanita F Kelley, Larry K Austin, Lata C Mathew, PhD, Laura Fontan, MS, Laurimer Kuilan Torres, LCDR Chad N Thompson, Leiyun Boone, PhD, Leonard H Lavi, Lestine C Webb, Libia M Lugo, Lillian S Wu, Lilly O Barton, Liming Zhang, Linda F Murphy, Linda Linh N Adams, Linda Thai, Ling Yu L Liu, Lisa Shin, Lixia Cai, Lloyd D Payne, Loretta J Jordan, Louis B Cencetti, Luis Mburgos Medero, Luis P Torres, Maan S Abduldayem, Mai X Huynh, Marcellinus D Dordunoo, Marcia B Williams, Marco S Esteves, Marcus F Yambot, Margaret L Bolte, Margaret M Annes, Maria C Agpaoa, Maria C Fermin, Maria Joselopez Barragan, PhD, Marie Falcone, Marie T Falcone, Marion Michaelis, Marissa S Steinhagen, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark A Tucker, Mark C Saale, Mark W Babbitt, Mark W Rivero, Maryam Tabatabaie, Matt D Suedkamp, Matthew B Casale, Matthew J Johnson, Maurice M Sheehan, Maxwell Van Tassell, PhD, Maxyne T Lam, Maya M Davis, Megan A Haggerty, Mei Chen Mu, Melanie M Walker, Melanie W Pishnery, Michael A Charles, Michael D Garcia, Michael D Kawalek, Michael E Maselli, Michael F Schuette, Michael R Goga, Michael S Araneta, Michael Shanks, MS, Michael T Cyrus, Michele L Glendenning, Michelle A Marsh, Michelle J Hines, Miguel A Martinez Perez, Mihaly S Ligmond, Minh D Phan, Mohsen Rajabi Abhari, FDA, Mra B Kamberem, Mra Davism, Mra M Barbosar, Nabeela J Chaudhry, Nancy L Rolli, Nayan J Patel, Nebil A Oumer, Nelly N Tran, Nicholas A Violand, Nicholas L Hunt, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Nicole E Knowlton, Norman Wong, Omotunde O Osunsanmi, Pal S Mayasandra, Paquita F Segarra, Parul M Patel, Patrick C Klotzbuecher, Paul A Bonneau, Paul L Bellamy, Pearl C Ozuruigbo, Peter Adams, PhD, Peter S Diak, Philip F Istafanos, DMV, MS, Phillip L Toy, Prabhu P Raju, Rachel C Stanton, Ralph A Erickson, Raymond T Oji, Raymond W Brullo, Rebecca K Olin, Rebecca Rodriguez, Reyes Candau Chacon, PhD, Richard L Friedman, Richmond K Yip, Robert C Coleman, Robert D Tollefsen, Robert Darius, Rochelle K Kimmel, Rocio Guzman Velazquez, Roger F Zabinski, Rona Leblanc, PhD, Ronald L Koller, Ronda Leblanc, Rumany C Penn, PharmD, Russell J Glapion, Ruth Moore, PhD, Saied A Asbagh, Saleem A Akhtar, Samantha J Bradley, Samina S Khan, Sandra A Boyd, Sandra L Shire, DMD, MPA, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Sarah Arden, Scott K Zika, Scott R Nichols, PhD, Sean P Desbrow, Selene T Torres, Seneca D Toms, Shannon B Ruelle, Sharon K Thoma, PharmD, Shirnette D Ferguson, Sidney B Priesmeyer, Sidonie J Takougang, Sonia R Peterson, Sony Mathews, Sonya L Karsik, RAC, Sparky L Bartee, Srinivas R Chennamaneni, PhD, Stanley Au, Stephanie A Slater, MS, Stephen D Brown, Steven D Kehoe, Steven E Porter, Jr, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Sudipan Karmakar, Sue Lee Chan, Sundy V Sedwick, Sunitha K Rajaram, PhD, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan T Hadman, Susanna E Ford, Taichun Qin, PhD, Tajah L Blackburn, Tamala P Bogan, Tamala P Magee, Tamara L Ely, Tamika White, Tanya E Malais, Ted L Anderson, Teresa I Navas, Teresa T Cain, Terrance L Thomas, Terri L Dodds, Thao T Kwan, Thao X Tran, Theresa Kirkham (NMI), Theressa B Smith, Thomas J Arista, Thomas R Beilke, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tina M Pawlowski, Torrance J Slayton, Toyin B Oladimeji, Tracey L Harris, Tracey T Duong, Trudy R Papson, Truong Xuan Nguyen (Andy), Tuan A Nguyen, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vashti E Bocker, Veronica Fuentes, MS, Vickie L Anderson, Virgilio F Pacio, CSO, Virginia Carroll, PhD, Walden H Lee, Wayne E Seifert, Wayne L Jefferson, Wendy G Tan, PhD, Wenzheng Wendy Zhang, William Hallett, PhD, William J Leonard, William S Vitale, Xiaohui Shen, Xiaoping Guan, Yasamin Ameri, Yi Wang, PhD, Youkeun Kim, Yumi J Hiramine, Yvette E Guillermo, Yvette Mlacour Davis, Yvins Dezan, Yvonne C Wilkes, Yvonne Y Wu, Zachary A Bogorad, Zhong Li, PhD, Zhongren Wu

Jennifer M Gogley's Documents

Publish Date Document Type Title
November, 2002 FDA 483 McGuff Pharmaceuticals, Inc. - Form 483, 2002-11-26
September, 2009 FDA 483 Defender SD Manufacturing LLC - Form 483, 2009-09-11
April, 2015 FDA 483 Avrio Biopharmaceuticals, LLC - Form 483, 2015-04-03
October, 2002 EIR Amphastar Pharmaceuticals, Inc. - EIR, 2002-10-09
June, 2001 EIR Amgen, Inc - EIR, 2001-06-08
May, 2015 FDA 483 Response Amgen, Inc - Form 483R, 2015-06-05
March, 2011 FDA 483 Alliance Medical Products, Inc. (dba Siegfried Irvine) - Form 483, 2011-03-23
June, 2010 FDA 483 McGuff Pharmaceuticals, Inc. - Form 483, 2010-06-02
September, 2013 FDA 483 Rentschler Biopharma SE - Form 483, 2013-09-20
November, 2008 FDA 483 Antibioticos Do Brasil Ltda - Form 483, 2008-11-06
November, 2017 FDA 483 Nitto Avecia Pharma Services, Inc. - Form 483, 2017-11-02
May, 2013 FDA 483 B. Braun Medical Inc. - Form 483, 2013-05-17
May, 2016 FDA 483 Response B. Braun Medical Inc. - Form 483R, 2016-06-01
November, 2006 FDA 483 Cephazone Pharma LLC - Form 483, 2006-11-06
June, 2015 EIR PYRAMID Laboratories, Inc. - EIR, 2015-06-05
August, 2011 EIR McGuff Pharmaceuticals, Inc. - EIR, 2011-08-24
June, 2011 FDA 483 Pacira Pharmaceuticals, Inc. - Form 483, 2011-06-17
March, 2019 FDA 483 McGuff Pharmaceuticals, Inc. - Form 483, 2019-03-26
January, 2008 FDA 483 Allergan Sales, LLC - Form 483, 2008-01-23
January, 2019 FDA 483 Opto-Pharm Pte Ltd - Form 483, 2019-01-25
November, 2002 EIR McGuff Pharmaceuticals, Inc. - EIR, 2002-11-26
February, 2014 EIR B. Braun Medical Inc. - EIR, 2014-02-13
September, 2003 FDA 483 Med-Pharmex, Inc - Form 483, 2003-09-12
August, 2011 FDA 483 McGuff Pharmaceuticals, Inc. - Form 483, 2011-08-24
August, 2012 EIR Teva Parenteral Medicines, Inc. - EIR, 2012-08-10
June, 2007 FDA 483 Abbott Medical Optics Inc. (AMO) - Form 483, 2007-06-25
May, 2010 EIR Teva Parenteral Medicines, Inc. - EIR, 2010-05-14
June, 2001 FDA 483 Amgen, Inc - Form 483, 2001-06-08
April, 2012 EIR Teva Parenteral Medicines, Inc. - EIR, 2012-04-24
July, 2015 FDA 483 Hartley Medical Center Pharmacy, Incorporated - Form 483, 2015-07-08
September, 2010 FDA 483 Defender SD Manufacturing LLC - Form 483, 2010-09-01
May, 2016 EIR B. Braun Medical Inc. - EIR, 2016-05-11
November, 2017 EIR Nitto Avecia Pharma Services, Inc. - EIR, 2017-11-02
June, 2001 FDA 483 Response Amgen, Inc - Form 483R, 2001-06-21
March, 2002 FDA 483 International Medication Systems, Ltd. - Form 483, 2002-03-08
February, 2006 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2006-02-23
July, 2014 FDA 483 ImprimisRx CA, Inc., dba ImprimisRx - Form 483, 2014-07-02
October, 2002 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2002-10-09
March, 2019 FDA 483 Response McGuff Pharmaceuticals, Inc. - Form 483R, 2019-04-16
January, 2015 FDA 483 Response PYRAMID Laboratories, Inc. - Form 483R, 2015-01-29
May, 2015 FDA 483 Amgen, Inc - Form 483, 2015-05-22
April, 2012 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2012-04-24
July, 2009 FDA 483 Cephazone Pharma LLC - Form 483, 2009-07-30
October, 2015 EIR Advanced Sterilization Products - EIR, 2015-10-28
March, 2017 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2017-03-31
June, 2015 FDA 483 PYRAMID Laboratories, Inc. - Form 483, 2015-06-05
March, 2005 FDA 483 ALS Group USA, Corp. - Form 483, 2005-03-17
May, 2015 EIR Amgen, Inc - EIR, 2015-05-22
November, 2011 FDA 483 Cephazone Pharma LLC - Form 483, 2011-11-17
March, 2006 FDA 483 McGuff Pharmaceuticals, Inc. - Form 483, 2006-03-22
May, 2010 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2010-05-07
May, 2013 EIR B. Braun Medical Inc. - EIR, 2013-05-17
November, 2008 EIR Antibioticos Do Brasil Ltda - EIR, 2008-11-06
November, 2013 EIR Advanced Sterilization Products - EIR, 2013-11-15
November, 2019 FDA 483 Ajinomoto Althea, Inc. - Form 483, 2019-11-22
February, 2008 EIR Genentech, Inc. - EIR, 2008-11-25
May, 2013 EIR Genentech, Inc. - EIR, 2013-05-23
March, 2003 FDA 483 B. Braun Medical Inc. - Form 483, 2003-03-26
October, 2019 FDA 483 Huons Co. Ltd._Jecheon Factory - Form 483, 2019-10-18
June, 2010 FDA 483 Michael Dean Berger MD - Form 483, 2010-06-10
November, 2013 FDA 483 Advanced Sterilization Products - Form 483, 2013-11-15
May, 2006 FDA 483 Haemonetics Manufacturing, Inc. - Form 483, 2006-05-23
March, 2016 EIR Avrio Biopharmaceuticals, LLC - EIR, 2016-03-23
February, 2014 FDA 483 B. Braun Medical Inc. - Form 483, 2014-02-13
January, 2015 EIR PYRAMID Laboratories, Inc. - EIR, 2015-01-15
March, 2012 FDA 483 Sandoz GmbH - Form 483, 2012-03-16
January, 2008 EIR Allergan Sales, LLC - EIR, 2008-01-23
May, 2016 FDA 483 B. Braun Medical Inc. - Form 483, 2016-05-11
March, 2016 FDA 483 Avrio Biopharmaceuticals, LLC - Form 483, 2016-03-23
January, 2015 FDA 483 PYRAMID Laboratories, Inc. - Form 483, 2015-01-15

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