FDA Investigator Janete F Guardia

Janete F Guardia has inspections in 18 countries as of 03 Nov 2023. Janete F Guardia has collaborated with a combinined 6266 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
218
Last Inspection Date:
03 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, India, China, Japan, Bulgaria, Ireland, Germany, Italy, Turkey, Belgium, Thailand, France, Switzerland, United Kingdom of Great Britain and Northern Ireland, Sweden, Malaysia, Costa Rica
Co-Investigator(s):
A Williams, Adams, Aditi S Thakur, Akbar J Zaidi, Alanna Lmussawwir Bias, Alia Legaux, Alice C Silva, Allen F Hall, Alysia M Salonia, Amanda B Athey, Amanda E Lewin, PhD, Amanda Jones, Andrace Lde Yampert, Andrea A Branche, Andria L Kuhlman, Anita Narula, PhD, Anita R Michael, Anthony C Warchut, Anthony E Keller, RPh, Anthony N Onianwa, Arindam Dasgupta, PhD, Ashley M Whitehurst, Azza Talaat, Barbara A Rusin, Barbara D Wright, Barbara J Holladay, Barbara J Rincon, Barbara Janine Breithaupt, Barbara M Frazier, Bonita S Chester, Brenna L Macdowell, Camille D Brown, Carl E Lovrich, Carr, CDR Sean T Creighton, Charles D Brown, Charles L Larson, Charles M Kerns, BLT DO, Christopher D Rush, Christopher Janik, Christopher M Elliott, Christopher R Richardson, Clotia Cabbey Mensah, Connie R Kiessling, Courtney N Long, Craig A Garmendia, Creighton T Tuzon, Cynthia A Harris, MD, RN, Cynthia F Kleppinger, MD, Cynthia T Cain, Daniel J Lahar, Daniel L Aisen, Danny D Horner, Darin S Wiegers, David J Gallant, David L Chon, David P Rice, David P Vanhouten, David R Heiar, Dawn C Olenjack, Debara R Reese, Deborah A Greco, Denise L Burosh, Diane C Thibodeau, Dien N Nguyen, Dominic R Frasca, Donna Ltartaglino Besone, Dorothy W Lee, Douglas S Joslin, Dr. Gopa Biswas, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Eduardo L Rodriguez, Edward D Mcdonald, Edward J Janik, Edward P Potter, Edwin Melendez, Eileen J Bannerman, Elizabeth B Griffin, Elkins, Ellen J Tave, Elvis D Morton, Emest F Bizjak, Eric C Schmitt, Eric M Mueller, PharmD, Erich P Garger, Erin L Mcfiren, Ernest Serna, III, Esaw, Evelyn Taha, Farhana Khan, Felix J Marrero, Francis J Eng, Frank J Marciniak, Gajendiran Mahadevan, PhD, Gale E Ryan, Gale L Glinecki, Gamal A Norton, Gene D Arcy, Geoffrey K Kilili, Gilbert Valdez Eps, II, Gilbert Valdez, RS, Gloria J Baca, MS, Gregson A Joseph, Habacuc V Barrera, Harperd, Hasan A Irier, PhD, Hector Cerros, Hector J Colon Torres, Helen B Ricalde, Himanshu Gupta, PhD, Holly S Simms, Iram R Hassan, PhD, Iris C Macinnes, Irons, Jacqueline S Warner, James M Simpson, James R Fleckenstein, James R Montero, James W Leonette, James W Plucinski, James W Whitney, Jamie D Swann, Jamie M Bumpas, Jane M Kreis, Janele F Guardia, Janet B Abt, Jay M Patria, Jeffery A Hangartner, Jeffrey A Reed, Jeffrey J Thibodeau, Jeffrey R Wooley, Jennifer C Adams, Jennifer Cunningham, Jeremy L Stukes, Jerry Lott, Jesse P Hardin, Jessica D Nanini, Jessica Fierros, RS, Jill J Tillman, Joanne E King, Joanne M Schlossin, Jocelyn C Turner, Jocelyn E Massey, Joel D Hustedt, Joel D Martinez, Joey C West, Johann M Fitch, John A Hollings, John A Iwen, John A Sciacchitano, John Dan, John J Thibodeau, John P Shelton, Johnson, Jonathan B Lewis, Jonee J Mearns, Joppie, Jose Acruz Gonzalez, Jose Alopez Rubet, Joseph A Morkunas, Joseph L Despins, PhD, Joseph W Matthews, Joshua D Levin, Joy P Matthias, Joyce A Kellett, Juanita Banuelos, Jude C Dikes, Justin A Hefferman, Jyoti B Patel, PhD, K Gonzlez, Kara A Scheibner, PhD, Karen A Spencer, Karen L Kosar, Katarzyna Plona, Katlin N Stubbs, Kelli N Hicks, Kellia N Hicks, Kellie L Thommes, RN, Kelvin Cheung, Kent A Conforti, Kevin A Gonzalez, Kimberly M White, Kristin N Longfellow, Kwong P Lee, Lakecha N Lewis, Lance M De Souza, MBA, Latorie S Jones, Lauren M Lawrance, Laurie B Frazier, LCDR Angelica M Chica, Leighton K Ngai, Leonard H Lavi, Li Hongpaul Yeh, PhD, Libia M Lugo, Linda Agregory Duty, Linda R Kuchenthal, Lisa Hayka, Lisa M Lopez, Lisa P Oakes, Loretta Nemchik, Lori A Gioia, Lori S Lawless, Louis Christy, Luis A Salinas, Luis M Burgos Medero, M Patriciaurphy Murphy, Makini Cobourne Duval, PhD, Marc R Dickens, Marc S Neubauer, Marcia G Evans, Margaret M Annes, Margarita Santiago, Marijo B Kambere, PhD, Marilyn M White, Mark R Mcclain, Maryam Tabatabaie, Matthew B Casale, Matthew C Watson, Matthew M Henciak, Maura Rooney, Maya M Davis, Megan A Haggerty, Meisha A Mandal, Melanie W Pishnery, Meredith L Sheridan, Merideth K Rose, Miah Jung, Miaja Umaedi, Michael F Skelly, PhD, Michael G Mayfield, Michael J Nerz, Michael J Pasternak, Michael P Anthony, Michael R Goga, Michelle J Hines, Michelle M Noe, Miguel A Martinez, Mikayla K Deardorff, Mike M Rashti, Milan S Mcgorty, Mildred L Mccray, Minh D Phan, Mohamad A Chahine, Mohsen Rajabi Abhari, FDA, Monique Rac Lester, Msdap Gonzlezk, Muralidhara B Gavini, PhD, Myra L Gemmill, Nadeem I Chaudhry, Natasha A Dezinna, Nathan R Moon, Nicholas C Mendiola, Nicholas P Schaub, Nicholas Z Lu, Nicola M Fenty Stewart, Norma Wong, Norman Wong, Osama A Khatib, Osama M Hamoud, P John Kamthong, Parul M Patel, Patricia A Homola, Patricia A Mcilroy, Paul L Figarole, Jr, Paula J Bretz, Pauline N Logan, Perry H Gambrell, Peter E Baker, Peter R Lenahan, Philip W Beck, Quynh H Strandberg, Rafael E Arroyo, Rebecca A Coleman, Rebecca B Welch, Rebecca E Dombrowski, Rebecca T Davis, Regina T Brown, Rene R Ramirez, Richard W Berning, Robert T Lorenz, Rodriguez, Ronda Loyd Jones, Ronda R Loyd Jones, Rose Ljean Mary, Rose M Ashley, Roy Baby, Ruben C Ayala, PharmD, Rupa Pradhan, S Lori Brown, PhD MPH, Saijal P Naik, Sam H Haidar, PhD, Samir C Gala, Sandra A Hughes, Sandra S Saniga, Scott B Laufenberg, Scott R Nichols, PhD, Shafiq S Ahadi, Sharon K Gershon, Sherri J Jackson, Sherrie L Krolczyk, Slater K Bartlett, Solomon Yimam (SY), Sony Mathews, Sripal R Mada, PhD, Staci G Mcallister, Stanley B Eugene, BS, BME, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephen C Smith, Stephen D Eich, Stephen L Beekman, Stephen R Souza, Steven A Gonzales, Steven R Ziser, Susanne M Richardson, MSc RAC ELS, Tamara N Champion, Tawny L Colling, Teddy Tom, Terri E Gibson, Thai T Duong, Thea C Grome, Theressa B Smith, Thomas J Arista, Thomas W Gordon, Timothy B Webb, Timothy C Grome, Timothy M Albright, Todd D Alspach, Todd J Maushart, Tonia F Bernard, Tony T Yang, Tracy R Ball, Tricia S Martinez, Troy R Petrillo, Valeria A Moore, Valerie G Vallely, Ve Garcia, Victoria M Daddeo, Vivian Garcia, Wendy A Johnecheck, William H Linkroum, Xiaohan Cai, PhD, Xiaojun Yan, Xiaokuang Lai, PhD, Xikui Chen (nmi), PhD, Yaw O Osei, Yiyue Zhang (nmi), PhD, Young M Choi, PhD, Zachary A Bogorad, Zachary L Miller, Zerita White, Zhongren Wu

Janete F Guardia's Documents

Publish Date Document Type Title
March, 2014 EIR Khalid Mahmood - EIR, 2014-03-05
January, 2022 FDA 483 Lifepoint Research, LLP - Form 483, 2022-01-14
October, 2018 FDA 483 Vimta Labs Limited - Form 483, 2018-10-26
July, 2014 EIR Ricca Chemical Company LLC - EIR, 2014-07-23
January, 2020 FDA 483 Medilink Hospital and Research Center - Form 483, 2020-01-21
January, 2010 FDA 483 Brymill Corporation - Form 483, 2010-01-12
November, 2014 FDA 483 Texas Biostetic Instruments - Form 483, 2014-11-18
July, 2016 FDA 483 Simpro - Form 483, 2016-07-07
August, 2015 FDA 483 Changzhou Kanghui Medical Innovation Co., Ltd. - Form 483, 2015-08-20
December, 2009 FDA 483 Kub Technologies, Inc. - Form 483, 2009-12-18
April, 2013 FDA 483 AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO. - Form 483, 2013-04-18
August, 2012 FDA 483 Healthy Spirit, LLC - Form 483, 2012-08-28
December, 2010 FDA 483 Medical Laser Systems Inc - Form 483, 2010-12-14
January, 2013 FDA 483 Human Biosciences, Inc. - Form 483, 2013-01-04
May, 2014 FDA 483 Inoveon Corporation - Form 483, 2014-05-21
February, 2013 FDA 483 DeRoyal Cientifica De Latinoamerica S.R.L. - Form 483, 2013-02-28
February, 2016 EIR Clinogent (formerly GVK Biosciences Pvt. Ltd.) - EIR, 2016-02-26
November, 2011 FDA 483 Blue Torch Medical Technologies, Inc. - Form 483, 2011-11-08
December, 2010 FDA 483 MEM, Inc. - Form 483, 2010-12-29
July, 2011 FDA 483 Hydrofera, LLC - Form 483, 2011-07-20
April, 2012 FDA 483 Karex Industries Sdn Bhd - Form 483, 2012-04-19
March, 2013 FDA 483 BD Medical - Form 483, 2013-03-14
September, 2021 FDA 483 VEEDA CLINICAL RESEARCH LIMITED - Form 483, 2021-09-03
February, 2015 FDA 483 Dental Republic - Form 483, 2015-02-09
October, 2010 FDA 483 Focus Medical, LLC - Form 483, 2010-10-06
May, 2014 EIR Sebotek Hearing Systems, LLC - EIR, 2014-05-16
December, 2019 FDA 483 Vimta Labs Limited - Form 483, 2019-12-18
July, 2013 FDA 483 Suzhou Armocon Technology Co.Ltd - Form 483, 2013-07-11
July, 2013 FDA 483 ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD - Form 483, 2013-07-04
May, 2012 FDA 483 SHENZHEN KINGYIELD TECHNOLOGY CO., LTD - Form 483, 2012-05-04
March, 2013 FDA 483 Asclepion Laser Technologies Gmbh - Form 483, 2013-03-07
August, 2015 EIR AMO (Hangzhou) Co., Ltd. - EIR, 2015-08-16
January, 2022 EIR Lifepoint Research, LLP - EIR, 2022-02-23
March, 2023 FDA 483 Ming Fai Industrial (Shenzhen) Co. Ltd - Form 483, 2023-03-10

Experience Redica System's 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.


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