FDA Investigator Denise M Visco, Investigator

Denise M Visco, Investigator has conducted inspections on 77 sites in 1 countries as of 03 Jan 2017. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
77
Last Inspection Date:
03 Jan 2017
Investigator Role:
FDA Investigator
Redica ID:
100008644
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with Denise M Visco, Investigator:
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Allen Lou, Amy Franklin, Amy Kim, Amy L Singer, Amy Lynn Frankshun, PhD, Amy M Cramer, Ana S Cabrera, Anastasia I Offordile, Andrea D Swingle, Andrew R Wasko, Annemarie B Randow, Annemarie Bodnar, Arindam Dasgupta, PhD, Atul J Agrawal, Barbara J Maulfair, Barbara Jwilimczyk Macri, Betsy C Galliher, Byungja E Marciante, Charles A Snipes, PhD, Charles J Chacko, Charles M Edwards, Cheryl A Grandinetti, Christina N Maurino, Christine M Cerenzio, Christopher J Adams, Daniel J Grabicki, Darin S Wiegers, David H Smith, Dawn L Wydner, Deborah B Nixon, Denise M Visu, Dolores Harper, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Abhijit Raha, PhD, Dr. Sriram Subramaniam, PhD, Edward O'shaughnessy, Emest F Bizjak, Emily A Walters, Emmanuel Jramos Maldonado, Eric Rothschild, Erin D Mccaffery, Esteban Beltran, Frank J Marciniak, Frederick F Razzaghi, George Pyramides, Guerlain Ulysse, Helen B Ricalde, Helen Verdel, Hyojong Kwon, PhD, Jacqueline A O'shaughnessy, PhD, James R Birkenstamm, Janet Donnelly, Jean Blackston Hill, Jean M Kelahan, Jennifer A Bazergui, Jennifer L Custodio, Jennifer Macmillan, Jessica M Monteiro, Joan A Loreng, Jogy George, Jonee J Mearns, Joy Rkozlowski Klena, Juanita P Versace, Justine Tomasso, Kara A Scheibner, PhD, Karen E D'orazio, Kassa Ayalew, MD, Kathleen B Swat, Kelli F Dobilas, Kelly I Anderson, Kerry A Kurdilla, Kevin Obrien, Kip J Hanks, Kish Bolden, Kristina L Conroy, Kristy A Zielny, Krystal O Ogunremi, Lata C Mathew, PhD, Lauren L Vajo, Lenahan Lenahan, Peter R, Liatte Kreuger, PharmD, Lisa Harlan, Lisa Mathew, Loretta Nemchik, Marcelo O Mangalindan, Jr, Marcia Gelber, Marea K Harmon, Margaret M Sands, Maria Estrella, Martin K Yau, PhD, Matthew A Spataro, Mayar M Mussa, Melissa A Freeman, Melissa B Libby, Melissa T Roy, Melkamu Getie Kebtie, PhD, Meredith L Sheridan, Meyer J Slobotsky, Michael F Skelly, PhD, Michael R Klapal, Michael Serrano, Michael Skelly, Michelle L Johnson, Mohsen Rajabi Abhari, FDA, Monika Borkowska, Myra K Casey, Namita Kothary, Nancy F Scheraga, Nancy M Espinal, Nerizza B Dalena, Nerizza B Guerin, Nicholas A Violand, Nikisha M Bolden, Nina Yang, Paul L Bellamy, Peter R Lenahan, Regina T Brown, Richard D Manney, Robert Jennings, Rodney T Allnutt, Russell J Glapion, Sam Chan, Sarah Forney, Schultz, Shirley S Wen, Sinai I Davis, Stephanie T Durso, Stephen J Mottola, Susan M Halsted, Tania E Garcia, Tania E Vizcaino, Tonia F Bernard, Tressa T Lewis, Tyanna N Hadley, Unnee Ranjan, Valerie C Reed, Valerie Reed, Vincent F Cafiso, William J Muszynski, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Xingfang Li, MD, Yvesna C Blaise, Zakaria I Ganiyu

Denise M Visco, Investigator's Documents

Publish Date Document Type Title
September, 2016 FDA 483 Somerset Medical Center IRB - Form 483, 2016-09-30
July, 2011 EIR Bristol Myers Squibb - EIR, 2011-07-27
April, 2015 FDA 483 Monmouth Medical Center IRB - Form 483, 2015-04-20
September, 2015 FDA 483 Response Ruemu Birhiray - Form 483R, 2015-09-17
February, 2016 EIR inVentiv Health clinical - EIR, 2016-02-16
April, 2012 FDA 483 Bristol Myers Squibb - Form 483, 2012-04-05
September, 2015 EIR Ruemu Birhiray - EIR, 2015-09-04
September, 2012 FDA 483 Syneos Health Clinical, Inc. - Form 483, 2012-09-14
September, 2016 EIR Somerset Medical Center IRB - EIR, 2016-09-30
March, 2011 FDA 483 Essex Institutional Review Board, Inc - Form 483, 2011-03-21
February, 2014 EIR Xenobiotic Laboratories, Inc. - EIR, 2014-02-25
November, 2010 FDA 483 LifeCell Corporation - Form 483, 2010-11-12
March, 2011 FDA 483 Response Essex Institutional Review Board, Inc - Form 483R, 2011-04-11
January, 2011 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2011-01-28
February, 2016 FDA 483 inVentiv Health clinical - Form 483, 2016-02-16
October, 2014 EIR Bristol-Myers Squibb Company - EIR, 2014-10-10
October, 2015 EIR Tandem Labs A LabCorp Company - EIR, 2015-10-02
January, 2013 EIR GE Healthcare, Inc. - EIR, 2013-01-30
April, 2012 EIR Bristol Myers Squibb - EIR, 2012-04-05
September, 2015 FDA 483 Ruemu Birhiray - Form 483, 2015-09-04
August, 2011 EIR Dr. Reddy'S Laboratories - EIR, 2011-08-19
January, 2011 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2011-01-28
November, 2010 FDA 483 Response LifeCell Corporation - Form 483R, 2010-12-01
August, 2010 FDA 483 Radpharm, Inc. - Form 483, 2010-09-02
March, 2011 EIR Essex Institutional Review Board, Inc - EIR, 2011-03-21
September, 2012 EIR Syneos Health Clinical, Inc. - EIR, 2012-09-14
January, 2013 FDA 483 GE Healthcare, Inc. - Form 483, 2013-01-30
April, 2015 EIR Monmouth Medical Center IRB - EIR, 2015-04-20
January, 2014 FDA 483 Response Cadila Healthcare Limited - Form 483R, 2014-01-31
August, 2011 FDA 483 Xenobiotic Laboratories, Inc. - Form 483, 2011-08-03
April, 2013 FDA 483 Shua-Haim, Joshua R. MD - Form 483, 2013-04-02
November, 2010 EIR LifeCell Corporation - EIR, 2010-11-12
January, 2012 FDA 483 Bristol Myers Squibb - Form 483, 2012-01-27
September, 2013 FDA 483 Product Safety Labs - Form 483, 2013-09-11
October, 2015 FDA 483 Tandem Labs A LabCorp Company - Form 483, 2015-10-02
September, 2014 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2014-10-24
April, 2014 FDA 483 NPS Pharmaceuticals, Inc. - Form 483, 2014-04-25
September, 2014 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2014-09-12
July, 2011 EIR Nelson Laboratories Fairfield Inc. - EIR, 2011-07-14
January, 2012 EIR Bristol Myers Squibb - EIR, 2012-01-27
April, 2015 FDA 483 Response Monmouth Medical Center IRB - Form 483R, 2015-05-01

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