FDA Investigator Dr. Gopa Biswas, PhD

Dr. Gopa Biswas, PhD has conducted inspections on 29 sites in 6 countries as of 30 Oct 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
29
Last Inspection Date:
30 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100008466
Countries of Inspections:
United States of America, India, Netherlands, France, Canada, Spain
FDA Investigators that have inspected at least one site in common with Dr. Gopa Biswas, PhD:
Aimee J Edwin, Alan P Kurtzberg, Alanna L Mussawwir Bias, Alia Legaux, Allen F Hall, Allen Lou, Amanda E Lewin, PhD, Amanda J White, Andrace L Deyampert, Arindam Dasgupta, PhD, Barbara Janine Breithaupt, Brandon C Heitmeier, Brandon L Mariner, Brandy D Brown, Brooke K Higgins, Candice C Mandera, Candice J Cortes, Carl A Anderson, Carmen Y Fisher, Carol Rivera Lopez, PhD, Charles R Bonapace, PhD, Charles R Cote, RIC, Chase Bourke, PhD, Corey K Reno, Courtney N Long, Craig A Garmendia, Cynthia A Harris, MD, RN, Cynthia M Goudeau, Daniel J Roberts, Daniel L Aisen, Dawn C Olenjack, Deborah B Nixon, Denise L Burosh, Dianne H Milazzo, Dina A Tallman, Dipesh K Shah, Dr. Abhijit Raha, PhD, Dr. Hansong Chen, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Elise A Murphy, Eric M Mueller, PharmD, Gajendiran Mahadevan, PhD, Gifford Whitehurst, Jr, Gregory W Smith, Hasan A Irier, PhD, Himanshu Gupta, PhD, Huixia Zhang, Hyojong Kwon, PhD, Ivis L Negron, Jacqueline A O'shaughnessy, PhD, James C Maclaughlin, James S Cartwright, Janete F Guardia, Jared P Stevens, Jasjeet K Sekhon, Jennifer C Adams, Joanne M Schlossin, John A Iwen, John A Kadavil, PhD, Jonathan G Matrisciano, Jose A Lopez, Jose Acruz Gonzalez, Justin A Boyd, Jyoti B Patel, PhD, Kara A Scheibner, PhD, Karen M Kondas, Kari M Johansen, Katherine Szestypalow, Kellia N Hicks, Kenneth H Williams, Kent A Conforti, Kham Phommachanh, Kimberly A Dux, Krystal O Ogunremi, Lakecha N Lewis, Laureen F Kononen, Laverne Puckett, LCDR Matthew R Mcnew, MPH, REHS/RS, Li Hongpaul Yeh, PhD, Linda Thai, Lisa B Orr, Lisa K Capron, Luella J Rossi, Makini Cobourne Duval, PhD, Maria V Price, Martin K Yau, PhD, Melkamu Getie Kebtie, PhD, Michael A Charles, Michael F Skelly, PhD, Michael G Sinkevich, Michael R Goga, Mohsen Rajabi Abhari, FDA, Mra Davism, Muralidhara B Gavini, PhD, Myra K Casey, Nadeem I Chaudhry, Natalie J Ayoub, Nathan R Moon, Nathaniel R Esaw, Nicola M Fenty Stewart, Nicole E Knowlton, Nikki S Ramirez, Pankaj H Amin, Parul M Patel, Paul A Bonneau, Paula J Bretz, Paula M Laplant, Perry H Gambrell, Peter R Lenahan, Rabin N Ghoshal, Rebecca T Davis, Richard W Berning, Rita K Kabaso, Ronald R Ruff, Ruben C Ayala, PharmD, Sam H Haidar, PhD, Samuel H Chan, PharmD, Sandra A Hughes, Scott B Laufenberg, Scott T Ballard, Sean Y Kassim, PhD, Seneca D Toms, Seongeun Cho (Julia), PhD, Sharon L Matson, Sherry L Secrist, BLT DO, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stephanie Mangigian, MS/OSH, RN, Steven A Gonzales, Susan D Yuscius, Susan M Jackson, Susanna E Ford, Tamal K Chakraborti, PhD, Tara C Singh, Tara K Carmody, Tawny L Colling, Terrance L Thomas, Theressa B Smith, Thomas J Arista, Traci C Kelm, Vickie J Kanion, Vivin George, William H Linkroum, Xiaohan Cai, PhD, Xiaokuang Lai, PhD, Xikui Chen (nmi), PhD, Yih Chain Huang, PhD, Yiying E Chen, Zhaoyang Meng

Dr. Gopa Biswas, PhD's Documents

Publish Date Document Type Title
June, 2014 FDA 483 Azidus Laboratories Limited - Form 483, 2014-06-21
September, 2015 EIR Ardea Biosciences, Inc. - EIR, 2015-09-25
July, 2014 EIR Cadila Pharmaceuticals Limited - EIR, 2014-07-04
March, 2018 EIR Citoxlab North America Inc - EIR, 2018-03-02
September, 2015 FDA 483 Ardea Biosciences, Inc. - Form 483, 2015-09-25
September, 2010 EIR PPD Development, L.P. - EIR, 2010-09-29
January, 2010 EIR PPD Development, L.P. - EIR, 2010-01-08
July, 2014 FDA 483 Response Zydus Lifesciences Limited - Form 483R, 2014-07-31
April, 2011 FDA 483 Pra International-early Development Services - Form 483, 2011-04-22
July, 2014 FDA 483 Zydus Lifesciences Limited - Form 483, 2014-07-10
April, 2011 EIR Pra International-early Development Services - EIR, 2011-04-22
March, 2011 EIR BASi Northwest Laboratory - EIR, 2011-03-04
February, 2013 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2013-02-15
April, 2014 EIR Medtox Laboratories, Inc. - EIR, 2014-04-03
July, 2014 FDA 483 Zydus - Cadila Healthcare Ltd. - Form 483, 2014-07-10
August, 2013 EIR Merck Sharp & Dohme - EIR, 2013-08-16
January, 2010 FDA 483 PPD Development, L.P. - Form 483, 2010-01-08
March, 2009 FDA 483 PPD Development, L.P. - Form 483, 2009-03-06

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