FDA Investigator Jose O Hernandez

Jose O Hernandez has inspections in 6 countries as of 25 Oct 2023. Jose O Hernandez has collaborated with a combinined 4106 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
67
Last Inspection Date:
25 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
India, United States of America, Israel, China, Italy, United Kingdom of Great Britain and Northern Ireland
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Aditi S Thakur, Alberto A Viciedo, Alice S Tsao, Allison A Aldridge, PhD, Althea A Williams, Amatul H Marium, Andrew J Garufi, Andrew M Abramowitz, Ann M Stewart, Anthony R Rauert, Arduino Frankovic, Arie C Menachem, Arthur G Hurst, Ashley Polizzotto, Atul J Agrawal, Barbara A Rusin, Bernice F Hirsch, Bijoy Panicker, Bo Chi, PhD, Brandy N Lepage, Bruce G Cooper, Burnell M Henry, Cameron J Smith, Carlos Chavez, Charanjeet Jassal, Charisse K Green, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Cheryl A Clausen, Christian Parra, Christine M Rivera, Christopher S Fields, Courtney N Long, Cynthia A Palmer, D Jennyxirakis Xiradakis, Daniel L Zheng, Danna E Solorzano, Dave M Deroche, David R Delucia, Dawn L Wydner, Deborah J Parris, Demitria J Xiradakis, Dilijeta Bajrami, Dipesh K Shah, Dongping Dai, PhD, Douglas A Campbell, Douglas G Ng, Dr. Robert C Horan, MD, Edmund F Mrak, Jr, Edouard Viard, Eric J Reisenauer, Erica B Raphael, Erik W Koester, Erin D Mccaffery, Felix Maldonado, Frank Verni, Frederick Razzaghi, Gale L Glinecki, Gam S Zamil, Ganesh N Joshi, Gary J Lader, Gary J Lehr, Gary T Greco, Gregson A Joseph, Guerlain Ulysse, Harry J Brewer, Hasan A Irier, PhD, Helen B Ricalde, Ilana Zigelman, Iram R Hassan, PhD, Irina Gaberman, Jacobson, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Liubicich, James A Liubieich, James D Bridges, Jason D Tenney, Jason Kwong, Jay B Shah, Jay T Wong, Jessica L Pressley, Joey V Quitania, Jogy George, John A Podsadowski, Johnna L Bleem, Jonah S Ufferfilge, Jose Acruz Gonzalez, Jose Ohernandez Guzman, Jose R Hernandez, Joseph Maselli, Joy P Matthias, Juandria V Williams, Juanita P Versace, Julie D Bringger, Julie Scoma, Karen L Kosar, Karishma G Gopaul, Karl Auguste, Kathleen M Jordan, Kathryn A Nagy, Kenneth G Klobus, Kenneth H Williams, Kent A Conforti, Kevin A Gonzalez, Kevin J Flessa, Kham Phommachanh, Kim Lthomas Cruse, Kim Thomasc Rice, Kimberley A Ricketts, Kimberly Y Smithson, Ko U Min, Kwong Lee, Kwong P Lee, Latorie S Jones, Lauren E Blaser, Lawrence W Farina, LCDR Chad N Thompson, Leiyun Boone, PhD, Liming Zhang, Lindsey M Schwierjohann, Loretta Nemchik, Lori M Newman, Luis A Dasta, Makini Cobourne Duval, PhD, Marcelo O Mangalindan, Jr, Margaret M Sands, Maria Estrella, Marie Bbuen Bigornia, Marion Michaelis, Mark R Mcclain, Marlene G Swider, Marlene L Davis, Matthew B Casale, Megan A Haggerty, Meredith P Soehl, Investigator, Michael A Charles, Michael Levin, Michael R Dominick, Michael R Klapal, Michele L Obert, Mindy M Chou, Mra Davism, Mra Mcculloughj, Nada F Agabani, Nailing Zhang, Nariman Patenaude, Nazmul Hassan, Nealie C Newberger, Neil J Bonzagni, PhD MPH, Nicholas A Violand, Nicholas C Mendiola, Omadevi Somai, Investigator, Paraluman S Leonin, Parul M Patel, Patricia Fhughes Troost, Patrick C Klotzbuecher, Patty P Kaewussdangkul, Paul L Bellamy, Paul Mouris, Paula A Trost, Peter Abel, Peter Caparelli, Peter R Caparelli, Prabhu P Raju, Pratik S Upadhyay, DDC, Preston M Lee, Rachael A Moliver, Raihan A Chowdhury, Ramon E Martinez, Randy L Self, Raymond M Lam, Regina T Brown, Robert C Steyert, Robert J Martin, Robert R Wilson, Rochelle K Kimmel, Ronald Ifraimov, Rose Ljean Mary, Russ E Davis, Russell J Glapion, Saied A Asbagh, Saleem A Akhtar, Samina S Khan, Samuel Mindaye, Sarah A Meehan, Satheesh Thomas, Scott B Laufenberg, Sean R Marcsisin, Shantelle I Hughes, Shari L Kahn, Sharon K Pederson, Sharon K Thoma, PharmD, Sheri L Stephenson, Shirley J Berryman, Shreya Shah, Smith, Sony Mathews, Sripal R Mada, PhD, State Agency, Stephanie T Durso, Steven D Kehoe, Steven J Libal, Susan W Ting, Syeda N Mahazabin, Tamara M Simpson, Tamil Arasu, PhD, Tanya R Syffrard, Thomas E Friel, Thomas J Mooney, Thuy T Nguyen, LCDR, Tina M Pawlowski, Tonia F Bernard, Toyin B Oladimeji, Tracy M Portelli, Uduak M Inokon, Walden H Lee, Wayne E Seifert, Wayne S Fortenberry, Wendy G Tan, PhD, Wendy Tam, William J Leonard, William P Chilton, Yan Wang, Yuyan Liang, Yvesna C Blaise, Yvins Dezan, Yvonne M Santiago, Zedong Dong, Zhihao Qiu (Peter), PhD, Zhong Li, PhD

Jose O Hernandez's Documents

Publish Date Document Type Title
September, 2019 FDA 483 Syntho Pharmaceuticals Inc. - Form 483, 2019-09-03
March, 2019 FDA 483 Yaopharma Co., Ltd. - Form 483, 2019-03-29
March, 2019 FDA 483 NingBo Huize Commodity Co.,Ltd. - Form 483, 2019-03-22
April, 2018 EIR Pharbest Pharmaceuticals, Inc. - EIR, 2018-04-18
June, 2016 FDA 483 Natrium Products, Inc. - Form 483, 2016-06-30
August, 2016 FDA 483 J.M. Murray Center, Inc. - Form 483, 2016-08-17
January, 2019 FDA 483 Tris Pharma Inc - Form 483, 2019-01-23
March, 2017 FDA 483 Jerome Stevens Pharmaceuticals, Inc. - Form 483, 2017-03-30
June, 2017 FDA 483 Response Aero Data Metal Crafters Inc - Form 483R, 2017-06-06
March, 2016 FDA 483 MSKCC RMIPC - Form 483, 2016-03-29
January, 2016 FDA 483 Topiderm, Inc. - Form 483, 2016-01-21
December, 2019 EIR InvaGen Pharmaceuticals, Inc - EIR, 2019-12-06
May, 2018 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2018-05-29
June, 2017 FDA 483 Aero Data Metal Crafters Inc - Form 483, 2017-06-06
March, 2019 FDA 483 Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd. - Form 483, 2019-03-15
April, 2016 FDA 483 Air Techniques Inc - Form 483, 2016-04-29
November, 2016 FDA 483 Allegiant Health - Form 483, 2016-11-02
June, 2019 FDA 483 Infusion Options, Inc. - Form 483, 2019-07-08
January, 2018 FDA 483 The Estee Lauder Inc - Form 483, 2018-01-26
May, 2018 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2018-05-29
February, 2018 EIR Gemini Pharmaceuticals, Inc. dba Plus Pharma - EIR, 2018-02-16
May, 2016 FDA 483 Velocity Pharma LLC - Form 483, 2016-05-18
February, 2018 FDA 483 Gemini Pharmaceuticals, Inc. dba Plus Pharma - Form 483, 2018-02-16
September, 2017 FDA 483 AllerQuest LLC - Form 483, 2017-09-19
December, 2015 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2015-12-02
November, 2018 EIR P & L Development, LLC - EIR, 2018-11-29
March, 2018 FDA 483 Response ImClone Systems LLC - Form 483R, 2018-03-27
June, 2019 FDA 483 Infusion Options Inc. - Form 483, 2019-06-25
December, 2018 EIR InvaGen Pharmaceuticals, Inc - EIR, 2018-12-19
July, 2017 EIR Alexion Pharmaceuticals, Inc. - EIR, 2017-07-21
April, 2018 FDA 483 Pharbest Pharmaceuticals, Inc. - Form 483, 2018-04-18
December, 2018 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2018-12-19
December, 2019 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2019-12-06
December, 2015 FDA 483 Buffalo Dental Manufacturing Co., Inc. - Form 483, 2015-12-22
June, 2017 EIR Aero Data Metal Crafters Inc - EIR, 2017-06-06
November, 2018 FDA 483 P & L Development, LLC - Form 483, 2018-11-13
May, 2017 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2017-05-05
November, 2017 FDA 483 Rafa Laboratories Ltd. - Form 483, 2017-11-13
October, 2018 FDA 483 Topiderm, Inc. - Form 483, 2018-10-09
June, 2017 FDA 483 Buffalo Pharmacies Inc - Form 483, 2017-06-23
July, 2017 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2017-07-21
March, 2018 FDA 483 ImClone Systems LLC - Form 483, 2018-03-09

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