FDA Investigator Karen M Rodriguez

Karen M Rodriguez has inspections in 11 countries as of 31 Oct 2023. Karen M Rodriguez has collaborated with a combinined 3271 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
200
Last Inspection Date:
31 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100002689
Country:
United States of America, United Kingdom of Great Britain and Northern Ireland, Thailand, Canada, Germany, Uruguay, Hungary, Mexico, Brazil, France
Co-Investigator(s):
A Williams, Aaron F Coleman, Adaliz Santaliz Cruz, Alec D Fabus, Alex J Wild, Alexander B Anderson, Althea A Williams, Amy M Cramer, Ana P Barido, Anabel Veiga, Andrea H Norwood, Angela E Glenn, Ashleigh P Barkans, Ashleigh P Wodushek, Ashley A Mutawakkil, Ashley A Segura, Barbara T Carmichael, Beira Montalvo, Benita C Okeke, Benjamin W Anderson, Bill Tacket, Jr, Brandi L Garbutt, Brandon J Brookens, Brandon P Thompson, Carolyn E Barney, Casey L Hamblin, CDR Ileana Barreto Pettit, CDR Sean T Creighton, Charles D Brown, Charles S Watson, Christina L Bigham, Christopher T Smith, Cindy Laboy, Clara E Santiago, Clausnitzer, Cody J Alley, Colleen M Aspinwall, Connie L Hannon Rabel, Craig A Garmendia, Cynthia A Harris, MD, RN, Damaris Y Hernandez, Daniel S Fam, Danielle S Pearson, Daryl D Javellana, David E Lowe, David M Wilkinson, David P King, Dawn M Braswell, Dawn M Mccabe, Dennis R Hock, Dianiris C Ayala, Dillard H Woody, Jr, Dionne D Arline, Don A Leeseberg, Dorothy P Kramer, Ebony D Sanon, Eduardo Carbonell, Edwards, Edwin J Gorney, Elkins, Emir Galevi, Emma R Schaefer, Eric R Holm, Ernest A Clausnitzer, Figarole, Frank D Ladson, Gabriel E Muniz, Gale E Ryan, German Rivera, Giovanna Serpa, Gisselle I Sensebe, Glenn S Quintanilla, Harperd, Heather M Bullock, Hector Vallellanes, Holly M Scott, Hunt, Israel Juarbe, Ivan E Reyes, Ivonne A Vicente, Jake T Lane, James E Frye, James To Neal, Jamie P Webb, Jamirya S Weatherly, Jason D Tenney, Jason P Aun, Jennifer Caycedo, Jennifer L Huntington, Jennifer Lalama, Jennifer M Donzanti, Jennifer M Menendez, Jessica A Stephens, Joann Walters Salvatierra, Joanne E King, Joey C West, John E Russell, John J Bernal, Jose E Melendez, DDC, Jose Velez, Joshua J Silvestri, K Gonzlez, Karen M Cruz Arenas, Karen M Montgomery (KMM), Karl D Hezel, Katherine Vargas Serrano, Kelly M Byers, Kimberly Lewandowski Walker, Laiza V Garcia, Laura M Lopez, LCDR Angelica M Chica, Leo J Lagrotte, Leslie A Jackanicz, Leslin M Coachman, Linda K Matheny, Lindsay R Hatch, Lisa A Warner, Lissette Paiz, Lori S Lawless, Luz I Collado, Lydia S Chan, M Aabel I, Marc Balzarini, Marc R Dickens, Marinee Flores Marrero, Martrice A Packer, Megan K Otero, Melanie G Warzala, Melanie W Pishnery, Mendoza, Mercedes B Mota, Michael C Lombardi, Michael D Gifford, Michelle S Dunaway, Monica Cburgos Garcia, Msdap Gonzlezk, Munoz, Nicholas T Domer, Nicole E Knowlton, Nicole K Buck, Nicole M Bell, Nikki S Bryant, Omayra Nrodriguez Ruiz, Ormond, Patricia A Mcilroy, Paul A Licata, Paula M Laplant, Phillip M Pontikos, Preston M Lee, Rachel A Peters, Rafael Padilla, Ramon H Pabon Aponte, Raymond A Lyn, Jr, Reynolds, Richard Jay Tucker, RS, Richard K Vogel, Rina Bhikha, Rodriguez, Ronald Ifraimov, Ronan F King, Roy Baby, Roy R Rinc, Ruth A Williams, Saijal P Naik, Sally Gopaul, Salvatore N Randazzo, Sergio E Delgado, Shaquenta Y Perkins, Sharon Giamberini, Sharon I Gundersen, Shavon L Square, Sheila P Barthelemy, Simone E Pitts, Sophia A Sands, Stacey A Meyer, Stacey L Witherwax, Stanley B Eugene, BS, BME, State Agency, Stephen C Smith, Stephen D Eich, Suzanne M Healy, Tania E Vizcaino, Teresa I Navas, Tina A Desorcy, Toby L Keaton, Valerie J Grecek Trinh, Victor D Medina, Victor Spanioli, Woody, Yehualashet A Gessesse, Youngjd

Karen M Rodriguez's Documents

Publish Date Document Type Title
November, 2022 FDA 483 InNeuroCo - Form 483, 2022-11-21
January, 2013 FDA 483 Intelligent Hearing Systems Corp. - Form 483, 2013-01-22
April, 2016 FDA 483 Craftmatic Industries, Inc. - Form 483, 2016-04-15
October, 2019 FDA 483 MANDELAY KFT - Form 483, 2019-10-17
September, 2015 FDA 483 Clinical Diagnostic Solutions, Inc. - Form 483, 2015-09-18
May, 2022 FDA 483 Legend Aerospace, Inc. - Form 483, 2022-05-27
May, 2023 FDA 483 Arthrex, Inc. - Form 483, 2023-05-05
September, 2016 FDA 483 Powers Medical Devices, LLC - Form 483, 2016-09-08
February, 2016 EIR ICU Medical de Mexico, S.A. de C.V. - EIR, 2016-02-18
March, 2018 EIR Republic Spine, LLC - EIR, 2018-03-14
July, 2017 FDA 483 Airgas Usa, LLC - Form 483, 2017-07-21
August, 2019 FDA 483 Mark Two Engineering Inc. - Form 483, 2019-08-06
June, 2017 FDA 483 Michael D. Williams, D.D.S., P.A. - Form 483, 2017-06-15
May, 2013 FDA 483 Capillus LLC - Form 483, 2013-05-16
June, 2015 FDA 483 Clearspec LLC - Form 483, 2015-06-24
October, 2014 FDA 483 JAS Diagnostics, Inc./Drew Scientific, Inc. - Form 483, 2014-10-02
May, 2019 FDA 483 Infinium Medical, Inc - Form 483, 2019-05-15
May, 2017 FDA 483 Poiesis Medical, LLC - Form 483, 2017-05-22
March, 2016 FDA 483 Response Medscience Research Group Inc - Form 483R, 2016-04-14
December, 2012 FDA 483 Stingray Surgical Products, LLC - Form 483, 2012-12-07
June, 2019 FDA 483 Orthopedic Designs North America, Inc. - Form 483, 2019-06-12
February, 2023 FDA 483 Engineered Medical Systems, LLC - Form 483, 2023-02-10
December, 2022 FDA 483 Merits Health Products, Inc. - Form 483, 2022-12-06
March, 2015 FDA 483 Powers Medical Devices, LLC - Form 483, 2015-03-09
July, 2015 FDA 483 Groman Inc. - Form 483, 2015-07-10
April, 2014 FDA 483 Soteria Medical, LLC - Form 483, 2014-04-25
February, 2019 FDA 483 Curonix LLC - Form 483, 2019-02-15
November, 2018 FDA 483 CooperVision Lens Care Limited - Form 483, 2018-11-15
March, 2023 FDA 483 Cambridge Diagnostic Products, Inc. - Form 483, 2023-03-16
July, 2017 FDA 483 Applied Neuroscience, Inc. - Form 483, 2017-07-19
August, 2019 EIR Mark Two Engineering Inc. - EIR, 2019-08-14
September, 2016 FDA 483 Isolux, LLC - Form 483, 2016-09-14
July, 2018 FDA 483 Heartware, Inc. - Form 483, 2018-07-12
October, 2022 FDA 483 Silhouet-Tone (USA), Inc - Form 483, 2022-10-21
March, 2022 FDA 483 Advance-Esthetic LLC - Form 483, 2022-03-15
July, 2017 FDA 483 Acuderm, Inc. - Form 483, 2017-07-13
August, 2023 FDA 483 Myriad Medical, LLC - Form 483, 2023-08-17
December, 2017 FDA 483 Fen Dental Manufacturing, Inc. - Form 483, 2017-12-01
December, 2016 FDA 483 Biorep Technologies, Inc. - Form 483, 2016-12-06
February, 2014 FDA 483 AMS Diagnostics, LLC - Form 483, 2014-02-12
March, 2016 EIR Medscience Research Group Inc - EIR, 2016-03-29
December, 2015 FDA 483 International Medical Industries, Inc. - Form 483, 2015-12-18
July, 2017 EIR Acuderm, Inc. - EIR, 2017-07-13
February, 2022 FDA 483 Nikao, Inc. - Form 483, 2022-02-18
May, 2015 FDA 483 LD Technology, LLC - Form 483, 2015-05-05
March, 2016 FDA 483 Medscience Research Group Inc - Form 483, 2016-03-29
June, 2017 FDA 483 WINCHESTER LABORATORIES LLLP - Form 483, 2017-06-13
March, 2020 FDA 483 BioSculptor Corporation - Form 483, 2020-03-13
December, 2014 FDA 483 Scican Ltd. - Form 483, 2014-12-04
May, 2018 FDA 483 HNM Total Recon, LLC - Form 483, 2018-05-09
July, 2019 FDA 483 Boca Dental Supply LLC - Form 483, 2019-07-22
August, 2022 FDA 483 Biodominium Diagnostics - Form 483, 2022-08-12
October, 2016 FDA 483 Protech Professional Products, Inc. - Form 483, 2016-10-28
May, 2015 FDA 483 Vitalgo Inc. - Form 483, 2015-05-28
August, 2013 FDA 483 Dermatone USA, Inc - Form 483, 2013-08-06
February, 2017 FDA 483 Health-Chem Acquisitions, LLC - Form 483, 2017-02-03
May, 2013 FDA 483 Nikao, Inc. - Form 483, 2013-05-13
July, 2015 FDA 483 Lifesync Corporation - Form 483, 2015-07-24
December, 2019 FDA 483 LD Technology, LLC - Form 483, 2019-12-13
July, 2017 FDA 483 Response Acuderm, Inc. - Form 483R, 2017-08-02
December, 2014 FDA 483 TSO3 Inc. - Form 483, 2014-12-11
August, 2015 FDA 483 Innovative Therapies, Inc. - Form 483, 2015-08-27
April, 2022 FDA 483 JAS Diagnostics, Inc./Drew Scientific, Inc. - Form 483, 2022-04-28
September, 2017 FDA 483 Brit Systems - Form 483, 2017-09-01
January, 2023 FDA 483 THEWEB2U.COM, LLC - Form 483, 2023-01-23
September, 2022 FDA 483 OMT, LLC - Form 483, 2022-09-02
March, 2015 FDA 483 Insert Depot, Inc - Form 483, 2015-03-30
September, 2019 FDA 483 Tarmac Products, Inc. - Form 483, 2019-09-27
April, 2017 FDA 483 Marina Medical Instruments Inc. - Form 483, 2017-04-03
February, 2017 FDA 483 Response Health-Chem Acquisitions, LLC - Form 483R, 2017-02-27
May, 2016 FDA 483 Capillus LLC - Form 483, 2016-05-10
September, 2021 FDA 483 Heartware, Inc. - Form 483, 2021-09-30
December, 2017 FDA 483 Oculus Surgical, Inc. - Form 483, 2017-12-11
November, 2016 FDA 483 OMT, LLC - Form 483, 2016-11-15
February, 2020 FDA 483 Technological Medical Advancements LLC - Form 483, 2020-02-24
March, 2017 FDA 483 Mb Industria Cirurgica Ltda - Form 483, 2017-03-16
April, 2019 FDA 483 Pompano Precision Products, Inc. - Form 483, 2019-04-24
July, 2013 FDA 483 Macbrud Corporation - Form 483, 2013-07-25
August, 2015 FDA 483 Anodyne Medical Device Inc. - Form 483, 2015-08-13
September, 2022 FDA 483 Nagl MedTech - Form 483, 2022-09-20
October, 2011 FDA 483 Non-Invasive Monitoring Systems, Inc. - Form 483, 2011-10-28
February, 2023 FDA 483 New Wave Endo-Surgical, Corp. - Form 483, 2023-02-17
March, 2018 FDA 483 Republic Spine, LLC - Form 483, 2018-03-14
August, 2019 FDA 483 Response Mark Two Engineering Inc. - Form 483R, 2019-08-26
January, 2013 FDA 483 Kova Laboratories, Inc. - Form 483, 2013-01-10
July, 2017 FDA 483 Galix Biomedical Instrumentation, Inc. - Form 483, 2017-07-03
August, 2014 FDA 483 Craftmatic Industries, Inc. - Form 483, 2014-08-08
December, 2022 FDA 483 Cardiocommand Inc. - Form 483, 2022-12-09
October, 2019 FDA 483 Bedfont Scientific, Ltd. - Form 483, 2019-10-31
November, 2018 FDA 483 WEBER MEDICAL GMBH - Form 483, 2018-11-08
February, 2018 FDA 483 Mako Surgical Corporation - Form 483, 2018-02-23
January, 2013 FDA 483 Prime Enterprises - Form 483, 2013-01-03
January, 2020 FDA 483 Simple Diagnostics, Inc. - Form 483, 2020-01-08
September, 2023 FDA 483 Exactech, Inc. - Form 483, 2023-09-26
August, 2023 FDA 483 Ultra Clean Systems, Inc. - Form 483, 2023-08-11
October, 2023 FDA 483 J&T Health and Wellness LLC - Form 483, 2023-10-18
November, 2023 FDA 483 Home Health US, Incorporated - Form 483, 2023-11-20

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