FDA Investigator James R Montero

James R Montero has conducted inspections on 245 sites in 23 countries as of 13 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
245
Last Inspection Date:
13 May 2024
Investigator Role:
FDA Investigator
Redica ID:
100005304
Countries of Inspections:
United States of America, Indonesia, Sweden, Germany, China, Czechia, Romania, Brazil, Taiwan, United Kingdom of Great Britain and Northern Ireland, Japan, Netherlands, Switzerland, Poland, Singapore, Costa Rica, Italy, Hungary, Finland, Bulgaria, Argentina, France, Australia
FDA Investigators that have inspected at least one site in common with James R Montero:
Adam S Freeman, Ademola O Daramola, Alan Escalona, Alan P Kurtzberg, Alla Dubrovsky, Allen F Hall, Althea A Williams, Amanda S Zorn, Amy M Cramer, Anderson, Andrea J Schmidt, Andrew M Kolenc, Aqualia L Nelson, Ashleigh P Barkans, Ashleigh P Wodushek, Barbara J Rincon, Becky L Bhan, Blake R Jensen, Bodenw, Bonnie E Pierson, Brandi E Williams, Brandon K Lawson, Brenda G Stewart Munoz, Brent W Higgs, Brian R Hendricks, Bryan A Galvez, Bryan J Love, Bryce A May, Carla R Hinz, Caroline H Le, CDR Sean T Creighton, Charles D Brown, Charles L Larson, Christian D Lynch (CDL), Christin L Torres, Christina A Mayer, Christine E Kelley, Christine I Shaw, Christine L Williams, Christopher S Genther, Clinton K George, Constance M Dobbins, Courtney R Bratina, Courtney R Ingalsbe, Creighton T Tuzon, Cynthia L Gorveatt, Cynthia T Cain, Dana A Razzano, Daniel J Lahar, Daniel Pst Laurent, Danielle Lyke, Dannie E Rowland, Dave M Deroche, David A Gonzalez, David H Smith, Dawn M Braswell, Debara R Reese, Deborah A Nebenzahl, Deborah S Hammond, Debra L Curtis, Dennis G Kawabata, Dianiris C Ayala, Dolores Harper, Don A Leeseberg, Donna Ltartaglino Besone, Dr. Guang Gao, PhD, Ed Gonzalez Vazquez, Edith M Gonzalez, Efrain E Meneses, Elvin R Smith, Emily B Camire, Eric C Fox, Erika V Butler, Esteban Beltran, Evelyn Taha, Felicia M Orlando, Felix J Marrero, Finn A Slizza, Francis J Eng, Frank J Marciniak, Gene D Arcy, Gerard T Schneider, Ginger M Sykes, Glasgow Glasgow, Grace E Mcnally, Hanna L Potter, Holly L Miller, Hung V Le, Iris C Macinnes, Isabel Y Espinosa, Ivis L Negron, J Elkins, Jacey Roy, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Lane, James Coburn, James M Odonnell, James P Stallings, James R Fleckenstein, James W Whitney, Jamie L Dion, Janet Pulver, Janete F Guardia, Janice L Straight, Jd Young, Jennifer A Robinson, Jennifer L Wolfe, Jennifer M Pouget, Jennifer R Mathern, Jenny L Chisem, Jenny L Mccardell, Jessica L Johnson, Jessica M Ector, Jessie E Morris, Joel D Martinez, John A Sciacchitano, Jose Acruz Gonzalez, Joseph T Dougherty, Juan A Morales, Juanita Banuelos, Juanj N Wu, Judy Strojny Not In Use, Justin A Boyd, Justin H Erickson, Kamara Co, Karl D Hezel, Kathleen S Tormey, Kathryn M Mogen, Katlin N Stubbs, Kelly D Moore, Kelvin Cheung, Kevin N Tran, Kimberley A Hoefen, Kimberly Lewandowski Walker, Kimetha A King, Kristen E Szenderski, Laiza V Garcia, Lance D Johnson, Larisa E Pavlick, Laura A Grumenfelder, Laura B Kennedy, LCDR Matthew J Morrison, Leonard H Lavi, Lewis K Antwi, Li Li, Linda F Murphy, Linda Linh N Adams, Linda M Cheny, Lisa M Lopez, Lori A Carr, Lori J Silverstein, Lorie S Hannappel, Malik S Qaiser, Manuel A Moreno, Marc A Jackson, Jr, Marc S Neubauer, Marcia G Evans, Maribeth G Grattan, Maribeth G Niesen, Marie B Buen Bigornia, Marijo B Kambere, PhD, Marion W Nadeau, Mariza M Jafary, Mark S Frank, Martina E Lagrange, Mary F Bodick, Mary T Carden, Matthew A Johnson, Matthew A Kozler, Matthew A Walburger, Matthew J Hansen, Matthew M Vernon, Matthew R Dionne, Melissa A Zuppe, Melissa F Chauvin, Miaja Umaedi, Michael A Charles, Michael E Maselli, Michael J Kuchta, Michael K Larson, Michael L Jones, Michael R Goga, Michael W Shafer, Mihaly S Ligmond, Minerva Rogers, Monica Cburgos Garcia, Monica J Wilkins, Nancy Bogdanovic, Nancy L Neiger, Nathan M Jornod, Nathan R Moon, Nayan J Patel, Neira Acevedo Ramos, Nga T Ho, Nicholas L Hunt, Nicholas R Nance, Norman Wong, Omotunde O Osunsanmi, Patricia A Brown, Patricia A Cortez, Patricia A Maestas, Patrick E Gainer, Paul M Kawamoto, Paul Z Balcer, Paula A Trost, Pauline N Logan, Perry H Gambrell, Philip E Ake, Phillip J Sample, Phillip M Pontikos, Prabhu P Raju, Randy V Bong, Rebecca L Stephany, Rebecca S Secrist, Richard T Jensen, Ricki A Chase, Robert T Lorenz, Rodney D Combs, Ronald Ifraimov, Roy Baby, Roy C Stephens, Saied A Asbagh, Santiago Gallardo Johnson, Sara Jdent Acosta, Sara M Onyango, Scott K Zika, Scott R Izyk, Secrist, Sharon I Gundersen, Sheila Alaghemand, Shelley H Beausoleil, Shererk, Sherri J Jackson, Sherri N Rohlf, MD, Stanley B Eugene, BS, BME, Stephen C Smith, Stephen D Eich, Stephen R Souza, Stephen T Hansen, Steven C Madzo, Susan M Jackson, Suyang Qin, Teena H Aiken, Teresa K Kastner, Terri E Gibson, Terry C Kimball, Thaddeus M Steinke, Thai T Duong, Theressa B Smith, Thomas R Beilke, Traci B Bickell, Uros V Djekic, PhD, Vickie J Kanion, Vicky L Cruz, Vivian Garcia, Wayne W Grundstrom, William A Lanier, William F Lagud, Jr, William H Shackelford, Xiaokuang Lai, PhD, Yehualashet A Gessesse, Yvette E Guillermo, Zachary L Miller, Zachary L Stamm

James R Montero's Documents

Publish Date Document Type Title
February, 2024 FDA 483 Current Health Ltd - Form 483, 2024-02-15
January, 2024 FDA 483 Dynasthetics LLC - Form 483, 2024-01-11
November, 2023 FDA 483 OsteoCentric Technologies, Inc. - Form 483, 2023-11-13
November, 2015 FDA 483 Edwards Lifesciences, LLC - Form 483, 2015-11-20
March, 2019 FDA 483 Bloxr Solutions, LLC - Form 483, 2019-03-26
June, 2015 FDA 483 Zarbee's Inc - Form 483, 2015-06-17
June, 2016 EIR SupraNaturals, LLC - EIR, 2016-06-09
January, 2014 FDA 483 ASD Sleep, LLC dba American Sleep Dentistry - Form 483, 2014-01-24
June, 2019 FDA 483 Response BPI Labs - Form 483R, 2019-07-02
May, 2013 FDA 483 Summit Medical Products, Inc. - Form 483, 2013-05-10
April, 2015 FDA 483 Wu's Tech Co., Ltd. - Form 483, 2015-04-30
June, 2014 FDA 483 CoorsTek Medical LLC - Form 483, 2014-06-18
September, 2012 FDA 483 ASD Sleep, LLC dba American Sleep Dentistry - Form 483, 2012-09-21
June, 2019 FDA 483 CAO Group, Inc. - Form 483, 2019-06-05
June, 2017 EIR Sterigenics U.S., LLC - EIR, 2017-06-27
January, 2016 EIR Becton Dickinson and Company - EIR, 2016-01-08
March, 2016 FDA 483 Novarad Corporation - Form 483, 2016-03-30
September, 2019 FDA 483 Nexus CMF, LLC - Form 483, 2019-09-25
January, 2010 FDA 483 Integra LifeSciences Corp. d.b.a. Integra Pain Management - Form 483, 2010-01-20
May, 2015 EIR ELITechGroup, Inc. - EIR, 2015-05-27
November, 2022 FDA 483 Dynasthetics LLC - Form 483, 2022-11-03
November, 2017 FDA 483 Dynatronics Corporation - Form 483, 2017-11-09
November, 2019 FDA 483 KBD, Inc. - Form 483, 2019-11-08
April, 2014 FDA 483 Edwards Lifesciences, LLC - Form 483, 2014-04-15
June, 2016 FDA 483 Response SupraNaturals, LLC - Form 483R, 2016-06-29
March, 2020 FDA 483 Philips North America LLC - Form 483, 2020-03-25
May, 2018 FDA 483 ASD Sleep, LLC dba American Sleep Dentistry - Form 483, 2018-05-02
October, 2019 EIR Sterigenics U.S., LLC - EIR, 2019-10-29
May, 2023 FDA 483 Alpha ProTech Inc. - Form 483, 2023-05-11
September, 2018 FDA 483 Zevex Incorporated (dba MOOG Medical Devices Group) - Form 483, 2018-09-17
November, 2018 FDA 483 Rechargeable Power Energy North America LLC - Form 483, 2018-11-09
January, 2011 FDA 483 Inceptio Medical Technologies, L.C. - Form 483, 2011-01-27
July, 2019 FDA 483 Rocky Mountain Research, Inc. - Form 483, 2019-07-16
February, 2016 FDA 483 Trokamed GmbH - Form 483, 2016-02-19
August, 2019 FDA 483 SCHOTT CR, S.R.O. - Form 483, 2019-08-16
December, 2014 FDA 483 ZYTO Technologies, Inc. - Form 483, 2014-12-03
February, 2014 FDA 483 Endevr, LLC - Form 483, 2014-02-12
June, 2016 FDA 483 SupraNaturals, LLC - Form 483, 2016-06-09
May, 2023 FDA 483 Matia Robotics US, Inc. - Form 483, 2023-05-24
September, 2010 FDA 483 Summit Medical Products, Inc. - Form 483, 2010-09-24
June, 2017 FDA 483 Nytone Medical Products, Inc. - Form 483, 2017-06-05
May, 2023 FDA 483 Response Matia Robotics US, Inc. - Form 483R, 2023-05-24
August, 2019 FDA 483 SCHOTT Pharma AG & Co. KGaA - Form 483, 2019-08-14
October, 2023 FDA 483 Carrio Cabling Corporation - Form 483, 2023-10-27
December, 2023 FDA 483 Encore Medical, LP - Form 483, 2023-12-08
September, 2019 FDA 483 Dolor Technologies LLC - Form 483, 2019-09-19
March, 2012 FDA 483 Dynasthetics LLC - Form 483, 2012-03-29
May, 2015 FDA 483 ELITechGroup, Inc. - Form 483, 2015-05-27
December, 2011 FDA 483 Personal Performance Medical Corp - Form 483, 2011-12-14
December, 2018 FDA 483 SmartGuard Rx, Inc. - Form 483, 2018-12-12
November, 2015 EIR Edwards Lifesciences, LLC - EIR, 2015-11-20
February, 2012 EIR Nelson Laboratories, LLC - EIR, 2012-02-24
April, 2019 FDA 483 ICU Medical, Inc. - Form 483, 2019-04-04
December, 2022 FDA 483 ZYTO Technologies, Inc. - Form 483, 2022-12-13
June, 2012 FDA 483 Paragon Medical - Form 483, 2012-06-04
September, 2017 FDA 483 Diacor, Inc - Form 483, 2017-09-08
November, 2010 FDA 483 Fresenius USA Manufacturing - Form 483, 2010-11-16
March, 2017 EIR Merit Medical Systems, Inc. - EIR, 2017-03-15
October, 2019 FDA 483 VicTorch Meditek, Inc - Form 483, 2019-10-18
March, 2017 FDA 483 Medical Alignment Systems - Form 483, 2017-03-24
November, 2022 FDA 483 Reliance Medical Systems LLC - Form 483, 2022-11-17
February, 2017 FDA 483 BEKA Hospitec Gmbh - Form 483, 2017-02-02
June, 2022 FDA 483 Vela Operations USA, Inc. - Form 483, 2022-06-01
April, 2013 FDA 483 VMI Nutrition, Inc. dba Genysis Brand Solutions - Form 483, 2013-04-08
October, 2022 FDA 483 Hologic, Inc. - Form 483, 2022-10-14
June, 2019 FDA 483 BPI Labs - Form 483, 2019-06-12
March, 2022 FDA 483 KORR Medical Technologies, Inc. - Form 483, 2022-03-17
February, 2021 FDA 483 International Medical Development, Inc. - Form 483, 2021-02-12
July, 2014 FDA 483 Derma Pen, LLC - Form 483, 2014-07-22
February, 2011 FDA 483 Intravena, LLC - Form 483, 2011-02-17
March, 2019 FDA 483 Clinical Innovations, LLC - Form 483, 2019-03-15
April, 2017 FDA 483 Arlington Scientific, Inc - Form 483, 2017-04-19
October, 2011 FDA 483 Zevex Incorporated (dba MOOG Medical Devices Group) - Form 483, 2011-10-14
February, 2015 FDA 483 ForeverGreen International, LLC - Form 483, 2015-02-04
August, 2013 FDA 483 Providence Global Medical, Inc. - Form 483, 2013-08-29
July, 2014 FDA 483 Response Derma Pen, LLC - Form 483R, 2014-08-08
August, 2018 FDA 483 PT. TEAM-METAL INDONESIA - Form 483, 2018-08-08
March, 2011 FDA 483 Galloway Technologies, LLC - Form 483, 2011-03-02
October, 2018 FDA 483 J and L Grocery, LLC - Form 483, 2018-10-23
January, 2020 FDA 483 Unisis Corp. - Form 483, 2020-01-23
August, 2019 FDA 483 Waldemar Link GmbH & Co. KG (Mfg Site) - Form 483, 2019-08-22
October, 2019 FDA 483 Diacor, Inc - Form 483, 2019-10-03
May, 2016 EIR Edwards Lifesciences, LLC - EIR, 2016-05-20
October, 2014 FDA 483 F.P. Rubinstein Y Cia SRL - Form 483, 2014-10-17
September, 2022 FDA 483 ASD Sleep, LLC dba American Sleep Dentistry - Form 483, 2022-09-09
March, 2015 FDA 483 GE OEC Medical Systems, Inc - Form 483, 2015-03-25
September, 2023 FDA 483 B & D Dental Corp. - Form 483, 2023-09-05
November, 2011 FDA 483 International Health Technologies - Form 483, 2011-11-22
November, 2018 FDA 483 Zeller Power Products, LLC - Form 483, 2018-11-09
March, 2023 FDA 483 SteriGear, LLC - Form 483, 2023-03-22
January, 2020 FDA 483 Co-Innovation Biotect Co., Ltd. - Form 483, 2020-01-09
January, 2014 FDA 483 Nytone Medical Products, Inc. - Form 483, 2014-01-10
August, 2014 FDA 483 NatureAll-STF Holding, LLC - Form 483, 2014-08-15
May, 2011 FDA 483 Amedica Corporation - Form 483, 2011-05-13
May, 2022 FDA 483 Pyrexar Medical, Inc. - Form 483, 2022-05-18
October, 2016 FDA 483 Inovar Inc - Form 483, 2016-10-21
June, 2015 EIR Zarbee's Inc - EIR, 2015-06-17
May, 2012 FDA 483 Galloway Technologies, LLC - Form 483, 2012-05-17
March, 2011 FDA 483 SteriGear, LLC - Form 483, 2011-03-17
April, 2024 FDA 483 BioFire Diagnostics, LLC - Form 483, 2024-04-05
July, 2024 FDA 483 iRhythm Technologies, Inc. - Form 483, 2024-07-31

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