FDA Investigator Emmanuel Jramos Maldonado

Emmanuel Jramos Maldonado has conducted inspections on 48 sites in 3 countries as of 28 Sep 2020. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
48
Last Inspection Date:
28 Sep 2020
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
United States of America, India, Korea (Republic of)
FDA Investigators that have inspected at least one site in common with Emmanuel Jramos Maldonado:
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Allen Lou, Amatul H Marium, Amy L Singer, Amy M Cramer, Ankur C Patel, Ann Marie Montemurro, Annemarie Bodnar, Annet R Rajan, Anthony J Donato, Anthony M Criscuolo, Jr, Ashutosh Rao, PhD, Barbara J Maulfair, Barbara Jwilimczyk Macri, Bijoy Panicker, Brandy N Lepage, Byungja E Marciante, Carolina D Vasquez, Carolyn E Becker, Cary Greene, Charles J Chacko, Cheryl A Grandinetti, Christina N Maurino, Christine M Cerenzio, Constantin Y Philopoulos, Craig W Swanson, Crystal A Harlan, Cynthia Jim, CSO, Daniel J Grabicki, Daniel J Min, Darren S Brown, David A Oluwo, David H Smith, Dawn L Wydner, Deborah B Goffman, Deborah B Nixon, Denise M Visco, Investigator, Dhaval H Patel, Dinesh Kumar, Doan T Nguyen, PharmD, Dolores Harper, Donald C Obenhuber, PhD, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Edward O'shaughnessy, Elaine E Gilfillan, Emest F Bizjak, Eric Rothschild, Erin D Mccaffery, Frank J Marciniak, Frank Wackes, Freddy Ortiz Colon, Frederick F Razzaghi, Gabrielle J Swain, George Pyramides, Gianine E Delade, Gianine E Tompkins, Guerlain Ulysse, Haitao Li, Helen B Ricalde, Helen Verdel, James R Birkenstamm, Janet A Rajan, Jason M Sluzynski, Jawaid Hamid, Jay B Shah, Jean Blackston Hill, Jean M Kelahan, Jennifer Macmillan, Jessica M Monteiro, Jessica S Estriplet, Joan A Loreng, Jogy George, Jonah S Ufferfilge, Jonee J Mearns, Jose M Cayuela, Joseph F Mcginnis, RPh, Joy Rkozlowski Klena, Juanita P Versace, Junho Pak, Justin A Boyd, Justine Tomasso, Karen E D'orazio, Karishma G Gopaul, Kassa Ayalew, MD, Keith M Reilly, Kelli F Dobilas, Kelli Regente, Kelly Doremus, Kelly I Anderson, Kevin Obrien, Kinh Q Mac, Ko U Min, Krishnaiah Yellela, Kristy A Zielny, Laishan L Lam, Larry K Austin, Lata C Mathew, PhD, Lawrence Harmon, Jr, Lawrence R Johnson, Li Li, Liatte Kreuger, PharmD, Lisa Harlan, Louis G An, Luis A Dasta, Maotang Zhou, PhD, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Maria Estrella, Maria Manzoni, PhD, Marjorie D Schultz, Marvin D Jones, Matthew A Spataro, Matthew B Casale, Mayar M Mussa, Melba Trivera Clavell, Melissa A Freeman, Melissa B Libby, Melissa M Dauksis, Melissa M Schafer, Melissa T Roy, Meredith L Sheridan, Michael R Klapal, Michael Serrano, Michele Perry Williams, Miguel Gmanzano Maldonado, Monika Borkowska, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Naveen B Kanthamneni, Neda Hamandi, Nerizza B Guerin, Nicholas A Violand, Nicholas L Paulin, Niketa Patel, Nikki S Ramirez, Nina Yang, Pankaj H Amin, Paul L Bellamy, Peter R Lenahan, Regina T Brown, Remache, Richard D Manney, Richard W Thornton, Robert D Tollefsen, Robert Jennings, Robin P Mathew, Rodney T Allnutt, Rose Ljean Mary, Ruben C Quintana, Russell J Glapion, Sachinkumar V Patel, Saied A Asbagh, Saleem A Akhtar, Sangeeta M Khurana, PhD, Sanket N Patel, Sarah Adella Fave, Sarah Forney, Sayyem H Akbar, Schultz, Sean G Casey, Shahla Parvizi, Sherri J Liu, Sidney B Priesmeyer, Sinai I Davis, Stephanie T Durso, Stephen D Brown, Stephen J Mottola, Stephenie M Ortiz, Sunita Iyer, Susan M Halsted, Tamil Arasu, PhD, Tanya R Syffrard, Tara G Bizjak, Tara R Gooen, Tomika Crafter, Tomika L Crafter, Tonia F Bernard, Toyin B Oladimeji, Tracey L Harris, Tressa T Lewis, Tyanna N Hadley, Unnee Ranjan, Valerie C Reed, Valerie Reed, Victoria Spivak, Wayne J Meyer, William J Muszynski, William R Chang, Xiaohan Cai, PhD, Yong Wu, PhD, Youmin Wang, Yvesna C Blaise, Yvins Dezan, Zakaria I Ganiyu, Zhijin Chen

Emmanuel Jramos Maldonado's Documents

Publish Date Document Type Title
August, 2019 FDA 483 Water-Jel Technologies - Form 483, 2019-08-15
November, 2019 FDA 483 Far Hills Pharmacy - Form 483, 2019-11-14
September, 2019 FDA 483 Aurobindo Pharma Limited - Form 483, 2019-09-27
March, 2018 FDA 483 Renaissance Lakewood LLC - Form 483, 2018-03-15
September, 2018 EIR Novitium Pharma LLC - EIR, 2018-09-11
August, 2017 FDA 483 Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy - Form 483, 2017-08-31
August, 2016 FDA 483 Garonit Pharmaceutical, Inc. - Form 483, 2016-08-26
January, 2021 FDA 483 Imprimis NJOF, LLC - Form 483, 2021-01-29
December, 2016 FDA 483 Actavis Elizabeth LLC - Form 483, 2016-12-05
February, 2020 FDA 483 Aurolife Pharma LLC - Form 483, 2020-02-12
March, 2019 FDA 483 SPECTRUM LABORATORY PRODUCTS INC. dba SPECTRUM CHEMICAL MFG. CORP. - Form 483, 2019-03-12
September, 2017 FDA 483 Ingenus Pharmaceuticals NJ LLC - Form 483, 2017-09-27
February, 2017 EIR Amneal Pharmaceuticals, LLC - EIR, 2017-02-21
December, 2019 FDA 483 Response Halo Pharmaceuticals Inc. - Form 483R, 2020-01-13
February, 2017 FDA 483 Givaudan Flavors Corporation - Form 483, 2017-02-08
September, 2019 EIR Ipca Laboratories Limited - EIR, 2019-09-20
December, 2019 EIR Halo Pharmaceuticals Inc. - EIR, 2019-12-20
May, 2018 FDA 483 AustarPharma LLC - Form 483, 2018-05-23
June, 2019 EIR LTS Lohmann Therapy Systems Corp. - EIR, 2019-06-11
December, 2019 FDA 483 Halo Pharmaceuticals Inc. - Form 483, 2019-12-20
March, 2017 FDA 483 Nautical Foods, LLC - Form 483, 2017-03-28
January, 2019 FDA 483 Regi U.S. Inc. - Form 483, 2019-01-15
May, 2018 FDA 483 Ferring Production Inc. - Form 483, 2018-05-03
June, 2019 FDA 483 LTS Lohmann Therapy Systems Corp. - Form 483, 2019-06-11

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