FDA Investigator Cynthia A Harris, MD, RN

Cynthia A Harris, MD, RN has inspections in 25 countries as of 22 Sep 2023. Cynthia A Harris, MD, RN has collaborated with a combinined 7846 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
394
Last Inspection Date:
22 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Japan, Turkey, Denmark, Germany, Canada, Netherlands, Costa Rica, Ireland, India, Dominican Republic, China, Poland, Taiwan, South Africa, Mexico, Colombia, Singapore, Brazil, Sweden, Thailand, Serbia, Spain, Hungary, Italy
Co-Investigator(s):
A Ble Bevill, A Williams, Adaliz Santaliz Cruz, Adam C Hipko, Adrian Rodriguez, Akbar J Zaidi, Akbar Javed, Alan C Gion, Alanna Lmussawwir Bias, Alberto Gutierrez, PhD, Amanda B Athey, Amanda J White, Amber G Chung, Amy A Johnson, Amy M Cramer, Ana Delp Cintron, Ana P Barido, Anders W Evenson, Andrea A Branche, Andrew B Bevill, Angela Mock, Anh M Lac, Annabelle Crusan, D,VM, Annette Melendez, Anthony J Grace, Anya D Lockett Evans, Aqualia L Nelson, Arindam Dasgupta, PhD, Ashley, Ashley A Mutawakkil, Atul J Agrawal, Barbara A Crowl, Barbara A Gullick, Barbara J Holladay, Barbara Janine Breithaupt, Bernard P Heidt, Blondell W Johnson, Brackens Harris, Brandon L Mariner, Brenda G Stewart Munoz, Brenda Stewart Munoz, Brian J Ryan, Brian M Palermo, Brian S Keefer, Brian Sanders, Brittany L Carpenter, Brooke K Higgins, Bruce C Kovak, Byungja E Marciante, Calvin K Cook, Camille D Brown, Candice C Mandera, Candice C Mandero, Candice J Cortes, Cara Fiore, PhD, Carla C Tuite, Carol Mrivera Lopez, PhD, Carol Rivera Lopez, PhD, Carolyn E Barney, Casey L Hamblin, Catherine J Laufmann, Catherine Whiteside, PhD, CDR Sean T Creighton, Chaltu N Wakijra, Charles A Snipes, PhD, Charles D Brown, Charles E Idjagboro, Charles I Ann, Charles Kerns, Charles M Kerns, BLT DO, Charles M Spyr, Charles R Bonapace, PhD, Cherie T Parker, Chmura, Christian D Lynch (CDL), Christina D Mello, Christine I Shaw, Christine M Smith, Christine M Whitby, CSO, Christine Mwhitby Smith, Christopher D Rush, Clarice J Ahn, Connie Hannon Rabel, Connie L Hannon Rabel, Constance M Dobbins, Courtney N Long, Creighton T Tuzon, Cynthia Jim, CSO, Cynthia L Rakestraw, Cynthia T Cain, Da Lin Yao, MD, PhD, Dana M Lewis, Daniel G Walter, Daniel J Lahar, Daniel L Aisen, Daniel R Azar, Daniel R Tammariello, Daniel S Fam, Daniel T Lee, Danielle Lyke, Danielle S Pearson, Dannie E Rowland, Danny D Horner, Darla J Christopher, David A Oluwo, David J Gallant, David K Glasgow, David L Chon, David M Beltran, Deanne E Knapp, Debara R Reese, Deborah B Nixon, Debra Bower, Decarlos A Gomez, Denis Mackey, Denise D Dion, Denise L Burosh, Denise R Beuttenmuller, Deniza Karacic, Dennis R Hock, Diana L Ayala, Dianne H Milazzo, Douglas A Campbell, Dr. Abhijit Raha, PhD, Dr. Deanne Knapp, Dr. Gopa Biswas, PhD, Dr. Koffi A Amegadje, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Earl Echon, Ed Gonzalez Vazquez, Edmiston, Edward D Edmiston, Edward E Lockwood (EEL), Eleanor M Felton, Elisa M Fleming, Elise A Murphy, Elizabeth D Connell, Elkins, Ellen A Humphrey, Ellen J Tave, Elmina E Akwo, Elvis D Morton, Emest F Bizjak, Emmanuel A Dimaano, Jr, Eric E Joneson, Eric L Dong, BS, Erin L Mcfiren, Erin M Mcdowell, Felix J Marrero, Frederic W French, III, Fulton A Varner, Gabrielle J Swain, Gale L Glinecki, Gamal A Norton, Gerald D Bromley, Jr, Gerald Mierle, Gerald N Mcgirl, DDS, Gerald W Miller, Gifford Whitehurst, Jr, Gladys B Casper, Glasgow, Gloria A Milster, Gopa Bisivas, Grant, Grant L Davis, Gregory A Holt, Gregson A Joseph, H Ljamilla Selby, Habacuc V Barrera, Hala L Selby, Harperd, Hector J Colon Torres, Holly S Simms, Hugh M Mcclure, II, Huixia Zhang, Ian A Pilcher, Iris C Macinnes, Jacey Roy, Jackie O'shaughnessy, Jacob M Dyer, Jacob W Reynolds, Jacqueline A O'shanghnessy, PhD, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jacqueline N O'shaughnessy, Jaison J Eapen, James L Finn, James M Simpson, James P Mcreavey, James R Fleckenstein, James W Leonette, Jamie D Swann, Jamie P Webb, Janet B Abt, Janete F Guardia, Janice M Hickok, Jaqueline A O'shaughnessy, Jeanne D Shaffer, Jeanne Fringer, PhD, Jeffrey R Wooley, Jennifer Cunningham, Jennifer D Young, Jennifer Hua, Jennifer L Jager, Jennifer L Sheehan, Jennifer Owens Dowdy, Jeremy L Stukes, Jeremy W Rotton, Jesse P Hardin, Joanne M Schlossin, Jocelyn C Turner, Jodi M Gatica, Joel D Martinez, Joey C West, Johann M Fitch, John A Kadavil, PhD, John Dan, John J Walsh, John J Welsh, PhD, John Kadavil, PhD, John M Gusto, John S Hartford, Jonathan D Green, Jonathan W Chapman, Jose Martinez, Jr, Joseph A Morkunas, Joseph R Strelnik, Joshua D Levin, Juan A Morales, Jude C Dikes, Julie D Bringger, Jyoti B Patel, PhD, Kalavati Suvarna, PhD, Karen A Coleman, Karen C Daugherty, Karen M Cooper, Karen M Rodriguez, Karlton T Watson, Katelyn Astaub Zamperini, Katherine I Needleman, Kathleen M Jordan, Katlin N Stubbs, Kayla R Deatherage, Ke Zhang, Kelly J Pegg, Kelvin Cheung, Kenneth L Smalls, Kenneth Nieves, Khin Mang U, MD, Kimberly Lewandowski Walker, Kinh Q Mac, Krista N Flores, Kunapuli T Madhusudhan, Kurt A Brorson, PhD, Ladislav Kermet, Laine P Myers, Laiza V Garcia, Lakisha M Williams, Lance D Johnson, Latoya S Oliver Powell, Lauren E Skokan, Lauren N Barber, LCDR Anastasia Mpiliafas Brown, LCDR Wilfred A Darang, Leighton K Ngai, Leonard H Lavi, Li Lu, PhD, Linda S Mattingly, Lindsey L Kirsh, Lisa B Orr, Lisa M Puttonen, Lloyd D Payne, Loretta Nemchik, Lori S Lawless, Lorie S Hannappel, LT Melanie M Mayor, USPHS, Luann Mckinney, Lucilla Facchin, Lynette P Salisbury, Maira P Brading, Maotang Zhou, PhD, Marc R Dickens, Marc S Neubauer, Marcia G Evans, Marcus A Ray, Margaret H Waters, Margaret M Annes, Mariana F Baxter, Maribeth G Niesen, Marilyn M White, Marion W Nadeau, Marlo Ianm Alintanahin, Martin J Guardia, Martin K Yau, PhD, Martinez, Mary T Carden, Mathew R Manen, Matthew R Mcnew, Melissa D Kalik, Melissa J Garcia, Merelynn Rhoten, Merideth K Rose, Michael F Skelly, PhD, Michele L Glendenning, Michelle D Haamid, Michelle J Glembin, Mike M Rashti, Mildred L Mccray, Minerva Rogers, Monica J Wilkins, Monique Rac Lester, Monique S Frazier, Nadia R Barreda, Natasha A Dezinna, Natasha A Harry, Nathaniel R Esaw, Nebil A Oumer, Nichole J Chamberlain, Niraj Mehta, Norman K Starks, Norman Wong, Nutan Mytle, Olalere D Fasipe, Patricia A Morrow, Patrick C Klotzbuecher, Patrick D Stone, MS, Patty P Kaewussdangkul, Paul E Frazier, Paul M Kawamoto, Paul W Moy, Paula J Bretz, Pauline N Logan, Payne, Peter Kessler, PhD, Peter R Lenahan, Philip J Snoy, Philip M Steele, PhD, Phillip D Waldron, Phillip J Sample, Phillip M Pontikos, Pitman, Pratik S Upadhyay, DDC, Rachel C Harrington, Ralph H Vocque, Rebecca C O Bryan, Rebecca Rodriguez, Regina T Brown, Rhonda L Dash, Richard Heath Coats, Richard J Bashay, Robert G Ruff, Robert L Hummel, Robert T Harris, Robin R Waller, Rodney D Combs, Rodriguez, Ron Mabrysmelz, Ronald C Mabry Smith, Ronald Ifraimov, Ronald T Nowalk, Ronda R Loyd Jones, Rose M Ashley, Roy Baby, Russell J Glapion, Saijal P Naik, Sam H Haidar, PhD, Samuel H Chan, PharmD, Sandy J Ziegler, Scott R Nichols, PhD, Scott T Ballard, Sean M Cheney, Sean R Moynihan, MPH, Sean Y Kassim, PhD, Serajus Salaheen, Shannon A Gregory, Shawn E Larson, Sherrie L Krolczyk, Sherry I Seerist, Sherry L Secrist, BLT DO, Shusheen A Alexander, Srinivas R Chennamaneni, PhD, Stacey A Priest, State Agency, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Stephen C Eason, Stephen D Brown, Stephen D Eich, Stephen L Beekman, Stephen R Souza, Steven B Barber, Steven J Thurber, Steven P Donald, Steven R Ziser, Susan D Yuscius, Susan J Essenmacher, Susan Leibenhaut, MD, Susan M Jackson, Tamal K Chakraborti, PhD, Tamera H Hunt, Tamika E Allen, RN, Tania E Vizcaino, Tanika E Allen, RN, Terri E Gibson, Thai T Duong, Theresa Kirkham (NMI), Thomas A Peter, Thomas J Arista, Thomas R Withers, Tiki J Dixon, Timothy B Webb, Toby Vern H Hill, Tony T Yang, Torrance J Slayton, Toyin B Oladimeji, Tracey L Siebesma, Tracy J Washington, Tracy L Taras, Travis M Beard, Tricia S Martinez, Trina K Vick, Ve Garcia, Vivian Garcia, Viviana Matta, William A Warnick, William C Macfarland, William D Bassett, Jr, William H Linkroum, Xikui Chen (nmi), PhD, Yaw O Osei, Yih Chain Huang, PhD, Young M Yoon, Youngjd, Zhong Li, PhD, Zhongren Wu

Cynthia A Harris, MD, RN's Documents

Publish Date Document Type Title
September, 2011 FDA 483 Advantageous MD Llc - Form 483, 2011-09-13
August, 2002 EIR Anne-Marie Maddox, MD - EIR, 2002-08-23
April, 2009 FDA 483 Alberto R. Yataco, M.D. - Form 483, 2009-04-06
March, 2012 EIR Daniel J. Merenstein, MD - EIR, 2012-03-15
December, 2002 FDA 483 Response North Texas Institutional Review Board - Form 483R, 2002-12-17
April, 2002 FDA 483 Eagle Diagnostics, Inc - Form 483, 2002-04-16
December, 2015 FDA 483 Richard E. Ringel, M.D. - Form 483, 2015-12-17
July, 2016 EIR Advarra IRB - EIR, 2016-07-06
June, 2015 EIR Bioreliance Corporation - EIR, 2015-06-23
July, 2015 EIR BASI Gaithersburg, LLC - EIR, 2015-07-29
September, 2015 FDA 483 Yudhishtra Markan, MD - Form 483, 2015-09-09
September, 2009 FDA 483 Human Genome Sciences Inc - Form 483, 2009-09-21
December, 2002 FDA 483 William R Lumry, M.D. - Form 483, 2002-12-30
November, 2012 FDA 483 Futrex Tech, Inc. - Form 483, 2012-11-05
May, 2002 EIR Alcon Research LLC - EIR, 2002-05-30
March, 2012 FDA 483 U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2012-03-02
February, 2010 EIR ACell, Inc - EIR, 2010-02-03
March, 2012 FDA 483 Response Daniel J. Merenstein, MD - Form 483R, 2012-03-28
April, 2014 FDA 483 Angelini Pharma, Inc. - Form 483, 2014-04-22
May, 2004 EIR Alcon Research LLC - EIR, 2004-05-18
January, 2015 EIR U.S. Army Medical Research Institute of Infectious Diseases - EIR, 2015-01-21
November, 2002 FDA 483 Quest Medical, Inc. - Form 483, 2002-11-05
September, 2002 FDA 483 Response Douglas P Sinn, DDS - Form 483R, 2002-10-07
August, 2002 FDA 483 Anne-Marie Maddox, MD - Form 483, 2002-08-23
July, 2011 FDA 483 Industrial Municipal Equipment, Inc. (IME) - Form 483, 2011-07-26
April, 2002 EIR Eagle Diagnostics, Inc - EIR, 2002-04-16
January, 2002 EIR Alan Menter, MD/Clin Inv - EIR, 2002-01-18
August, 2014 FDA 483 CXL-USA, LLC - Form 483, 2014-08-29
June, 2016 FDA 483 Triaid, Inc. - Form 483, 2016-06-03
October, 2015 FDA 483 Wellstat Therapeutics Corporation - Form 483, 2015-10-07
February, 2013 EIR Valley Health/Winchester Medical Center IRB - EIR, 2013-02-01
August, 2004 EIR Dale Dental, Inc - EIR, 2004-08-31
December, 2012 FDA 483 Hemagen Diagnostics Inc - Form 483, 2012-12-20
January, 2011 FDA 483 Rebuilder Medical, Inc. - Form 483, 2011-01-11
June, 2016 EIR PAREXEL INTERNATIONAL CORPORATION - EIR, 2016-06-28
January, 2015 FDA 483 U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2015-01-21
July, 2009 FDA 483 Covance Laboratories, Inc. - Form 483, 2009-07-22
July, 2012 EIR Charles River Laboratories Inc. - EIR, 2012-07-31
August, 2003 FDA 483 Argon Medical Devices, Inc - Form 483, 2003-08-15
February, 2011 EIR Bioreliance Corporation - EIR, 2011-02-04
November, 2010 FDA 483 Nucletron Corporation - Form 483, 2010-11-18
December, 2002 EIR North Texas Institutional Review Board - EIR, 2002-12-17
September, 2010 EIR LifeNet Health - EIR, 2010-09-15
November, 2003 FDA 483 Carrington Laboratories, Inc - Form 483, 2003-11-19
December, 2002 FDA 483 North Texas Institutional Review Board - Form 483, 2002-12-17
April, 2014 EIR Angelini Pharma, Inc. - EIR, 2014-04-22
January, 2011 FDA 483 Aerscher Diagnostics, LLC - Form 483, 2011-01-19
February, 2013 FDA 483 Trinity Sterile, Inc. - Form 483, 2013-02-13
April, 2003 EIR Southwest Instrument Company - EIR, 2003-04-09
December, 2015 EIR Richard E. Ringel, M.D. - EIR, 2015-12-17
March, 2015 EIR Zhejiang Kindly Medical Devices Co., Ltd. - EIR, 2015-03-25
November, 2010 FDA 483 DeJarnette Research Systems, Inc. - Form 483, 2010-11-03
March, 2012 FDA 483 Daniel J. Merenstein, MD - Form 483, 2012-03-15
February, 2018 FDA 483 Erika D. Feller, MD - Form 483, 2018-02-08
April, 2002 EIR Charles River Laboratories - EIR, 2002-04-25
July, 2002 EIR Baxter Healthcare Corp - EIR, 2002-07-10
February, 2011 FDA 483 Bioreliance Corporation - Form 483, 2011-02-04
August, 2002 FDA 483 Response Anne-Marie Maddox, MD - Form 483R, 2002-09-06
July, 2002 EIR Henry A Punzi, MD - EIR, 2002-07-30
February, 2016 EIR Walter Reed Army Institute of Research (WRAIR) IRB - EIR, 2016-02-02
September, 2017 EIR Anna Olak-Popko, MD - EIR, 2017-09-19
August, 2004 FDA 483 Dale Dental, Inc - Form 483, 2004-08-31
February, 2013 FDA 483 Valley Health/Winchester Medical Center IRB - Form 483, 2013-02-01
September, 2010 FDA 483 Trinity Sterile, Inc. - Form 483, 2010-09-01
September, 2003 FDA 483 Osteomed, LLC - Form 483, 2003-09-11
October, 2010 FDA 483 Human Genome Sciences Inc - Form 483, 2010-09-24
November, 2008 FDA 483 Sitek Research Laboratories - Form 483, 2008-11-24
February, 2014 FDA 483 NovaSom, Inc. - Form 483, 2014-02-05
July, 2015 FDA 483 BioElectronics Corporation - Form 483, 2015-07-14
November, 2001 EIR Southwest Independent Irb - EIR, 2001-11-19
September, 2011 EIR Steven W. Boyce, M. D. - EIR, 2011-09-15
August, 2017 EIR Martin E. Gutierrez - EIR, 2017-08-09
December, 2002 EIR William R Lumry, M.D. - EIR, 2002-12-30
May, 2014 EIR Stephen N. Davis, MD - EIR, 2014-05-20
May, 2015 EIR Fisher Bioservices IRB - EIR, 2015-05-14
July, 2009 EIR Covance Laboratories, Inc. - EIR, 2009-07-22
September, 2003 EIR Osteomed, LLC - EIR, 2003-09-11
September, 2011 FDA 483 Steven W. Boyce, M. D. - Form 483, 2011-09-15
August, 2013 FDA 483 Everest Spine LLC - Form 483, 2013-08-20
June, 2003 EIR Jonathan R L Schwartz, Md/CIin Inv - EIR, 2003-06-04
April, 2003 FDA 483 Southwest Instrument Company - Form 483, 2003-04-09
March, 2002 EIR James T Hawa, DO - EIR, 2002-03-29
May, 2015 FDA 483 Fisher Bioservices IRB - Form 483, 2015-05-14
September, 2002 EIR Douglas P Sinn, DDS - EIR, 2002-09-19
October, 2015 EIR Wellstat Therapeutics Corporation - EIR, 2015-10-07
September, 2015 EIR Yudhishtra Markan, MD - EIR, 2015-09-09
September, 2002 FDA 483 Douglas P Sinn, DDS - Form 483, 2002-09-19
May, 2015 EIR Charles River Laboratories Inc. - EIR, 2015-05-28
January, 2002 FDA 483 Alan Menter, MD/Clin Inv - Form 483, 2002-01-18
July, 2002 FDA 483 Henry A Punzi, MD - Form 483, 2002-07-30
April, 2009 EIR Alberto R. Yataco, M.D. - EIR, 2009-04-06
December, 2015 FDA 483 Response Richard E. Ringel, M.D. - Form 483R, 2016-01-05
September, 2014 FDA 483 Action Products Incorporated - Form 483, 2014-09-22
January, 2016 FDA 483 Best Medical International, Inc. - Form 483, 2016-01-05
September, 2010 EIR PPD Development, L.P. - EIR, 2010-09-29
April, 2009 FDA 483 Response Alberto R. Yataco, M.D. - Form 483R, 2009-04-10
January, 2013 FDA 483 Visionary Optics, LLC - Form 483, 2013-01-22

Experience Redica System's 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