FDA Investigator Karen M Rodriguez

Karen M Rodriguez has conducted inspections on 202 sites in 11 countries as of 14 Nov 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
202
Last Inspection Date:
14 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Brazil, Canada, United Kingdom of Great Britain and Northern Ireland, France, Korea (Republic of), Mexico, Hungary, Thailand, Germany, Uruguay
FDA Investigators that have inspected at least one site in common with Karen M Rodriguez:
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, 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, Dolores Harper, Don A Leeseberg, Dorothy P Kramer, Ebony D Sanon, Eduardo Carbonell, Edwin J Gorney, Emir Galevi, Emma R Schaefer, Eric R Holm, Ernest A Clausnitzer, Figarole, Frank D Ladson, Frank J Marciniak, Gabriel E Muniz, Gale E Ryan, German Rivera, Giovanna Serpa, Gisselle I Sensebe, Glenn S Quintanilla, Heather M Bullock, Hector Vallellanes, Holly M Scott, Israel Juarbe, Ivan E Reyes, Ivonne A Vicente, J Elkins, Jake T Lane, James E Frye, James To Neal, Jamie P Webb, Jamirya S Weatherly, Jason D Tenney, Jason P Aun, Jd Young, 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, Jr, John J Bernal, José E Meléndez, Jose Velez, Joshua J Silvestri, K Gonzlez, Karen M Cruz Arenas, Karen M Montgomery (KMM), Karl D Hezel, Katherine V 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 A Abel I, Marc Balzarini, Marc R Dickens, Marinee Flores Marrero, Martrice A Packer, Matthew T Sanchez, 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, 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, Stephen C Smith, Stephen D Eich, Suzanne M Healy, Tania E Vizcaino, Teresa I Navas, Tina A Desorcy, Toby L Keaton, Ulysses D Singleton, Valerie Jgrecek Trinh, Victor D Medina, Victor Spanioli, Woody, Yehualashet A Gessesse

Karen M Rodriguez's Documents

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

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