FDA Investigator Dennis G Kawabata

Dennis G Kawabata has conducted inspections on 135 sites in 1 countries as of 01 Sep 2009. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
135
Last Inspection Date:
01 Sep 2009
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with Dennis G Kawabata:
Alexander M Kay, Althea A Williams, Amy M Cramer, Ashleigh P Barkans, Astrida B Mattson, Ava M Bowman, Avery J Dennis, Barbara J Rincon, Brenda L Reihing, Brian R Hendricks, Bryan Baker, Bryce E Mansfield, Carl A Anderson, Catherine J Laufmann, Celeta S Coves, Celia L Silverstein, Charles L Larson, Christine M Parmentier, Christopher R Czajka, Christopher S Genther, Creighton T Tuzon, Cynthia L Gorveatt, Dan G Eisenbrey, Deborah A Nebenzahl, Denise M Zavagno, Dennis R Hudson, Dianna D Wardlow Dotter, Dolores E Price, Dolores Harper, Donald B Mckechnie, Eileen M Malecki, Elmina E Akwo, Francis J Eng, Frank J Marciniak, Gary L Zaharek, Gloria J Baca, MS, Gobiga Vanniyasingam, Graham N Giesen, Heika R Tait, James A Lane, James C Henry, James D Hildreth, James R Fleckenstein, James R Montero, Jessica L Walters Moell, Jocelyn T Ramos, John A Hall, John E Emmert, Jonathan Ho, Julian C Hanson, K Gonzlez, Kathryn A Krentz, Kelly D Sheppard, Kerri E Butler, Lauren E Swantko, Lawrence Y Lee, PhD, LCDR Ismael Olvera, IV, Lisa K Capron, Lori J Silverstein, Lorna F Jones, Margo C Jones, Maria Pkelly Doggett, MBA, Marlene L Davis, Marlo Ianm Alintanahin, Michael F Schuette, Michael J Lackey, Msdap Gonzlezk, Naakesh N Gomanie, Nancy A Saxenian Emmons, Nataniel Phillips Sylvain, PhD, Norman Wong, Paul Kawamoto, Paul M Kawamoto, Peter Kessler, PhD, Philip E Ake, Phillip M Pontikos, Rebecca L Stephany, Rebecca T Davis, Robert D Tollefsen, Rocco C Black, S Lori Brown, PhD MPH, Sangeeta M Khurana, PhD, Scott A Nabe, Sharon I Gundersen, Sherri N Rohlf, MD, Stanley B Eugene, BS, BME, Stephen R Souza, Steven R Ziser, Sunitha K Rajaram, PhD, Suzie L Kent, Terri E Gibson, Vanessa Y Jacobs, Victor A Meo, William R Chang, Xiaojun Yan

Dennis G Kawabata's Documents

Publish Date Document Type Title
October, 2003 EIR Spacelabs Healthcare Inc - EIR, 2003-10-28
April, 2000 FDA 483 Ameritek USA, Inc. - Form 483, 2000-04-13
April, 2008 FDA 483 Philips North America LLC - Form 483, 2008-04-21
August, 2003 FDA 483 Acumed LLC - Form 483, 2003-08-05
October, 2000 EIR Philips North America LLC - EIR, 2000-10-10
October, 2003 FDA 483 Spacelabs Healthcare Inc - Form 483, 2003-10-28
February, 2000 FDA 483 Physio-Control, Inc. - Form 483, 2000-02-11
May, 2005 FDA 483 Response Physio-Control, Inc. - Form 483R, 2005-04-18
October, 2000 FDA 483 Response Philips North America LLC - Form 483R, 2000-10-20
December, 2000 EIR Ameritek USA, Inc. - EIR, 2000-12-08
July, 2008 FDA 483 Pneumex, Inc. - Form 483, 2008-07-29
December, 2003 FDA 483 Response Roger P. Simon, Clinical Investigator - Form 483R, 2003-12-22
July, 2000 EIR Blood Bank Computer Systems, Inc. - EIR, 2000-07-05
August, 2003 FDA 483 Myotronics-Noromed Inc - Form 483, 2003-08-15
August, 2003 EIR Myotronics-Noromed Inc - EIR, 2003-08-15
August, 2000 EIR Welch Allyn Protocol, Inc - EIR, 2000-08-16
August, 2004 EIR Northwest Medical Physics Equipment Inc - EIR, 2004-08-06
May, 2005 FDA 483 Physio-Control, Inc. - Form 483, 2005-03-31
February, 2001 EIR Physio-Control, Inc. - EIR, 2001-02-06
February, 2000 FDA 483 Response Physio-Control, Inc. - Form 483R, 2000-03-02
July, 2001 FDA 483 Plexus NPI Plus - Form 483, 2001-07-13
April, 2000 EIR Ameritek USA, Inc. - EIR, 2000-04-13
July, 2003 FDA 483 Westone Laboratories, Inc. - Form 483, 2003-07-09
August, 2004 FDA 483 Northwest Medical Physics Equipment Inc - Form 483, 2004-08-06
June, 2001 EIR Welch Allyn Protocol, Inc - EIR, 2001-06-26
October, 2005 FDA 483 The Electrode Store, Inc. - Form 483, 2005-10-06
August, 2003 EIR Acumed LLC - EIR, 2003-08-05
August, 2001 EIR Philips Ultrasound, Inc. - EIR, 2001-08-01
October, 2000 FDA 483 Philips North America LLC - Form 483, 2000-10-10
November, 2003 EIR Stephen F. Quinn, M.D. - EIR, 2003-11-05
April, 2003 FDA 483 Oregon Health & Science University IRB - Form 483, 2003-04-25
August, 2003 FDA 483 Response Myotronics-Noromed Inc - Form 483R, 2003-08-21
December, 2003 FDA 483 Roger P. Simon, Clinical Investigator - Form 483, 2003-12-05
October, 2009 FDA 483 Cardiac Science Corporation - Form 483, 2009-10-01
August, 2004 FDA 483 Response Northwest Medical Physics Equipment Inc - Form 483R, 2004-10-01
November, 2003 EIR Peace Health Institutional Review Board Peacehealth - EIR, 2003-11-03
December, 2003 EIR Roger P. Simon, Clinical Investigator - EIR, 2003-12-05
July, 2003 EIR Westone Laboratories, Inc. - EIR, 2003-07-09
September, 2001 FDA 483 Clear Medical, Inc. - Form 483, 2001-09-19
August, 2000 FDA 483 Welch Allyn Protocol, Inc - Form 483, 2000-08-16
May, 2001 FDA 483 Surgical Instruments Service & Savings, Inc. - Form 483, 2001-05-25

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