FDA Investigator Jesse P Romenesko

Jesse P Romenesko has conducted inspections on 744 sites in 7 countries as of 07 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
744
Last Inspection Date:
07 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Belgium, Iceland, Guatemala, Mexico, Fiji, Peru
FDA Investigators that have inspected at least one site in common with Jesse P Romenesko:
Aaron L Dunbar, Abram A Brown, Alecia L Marson, Alfred P Pistorio, Alison A Nicoli, Amir Alavi, Amy L Mcintyre, Ana E Morales, Anders W Evenson, Anthony P Duran, April L Brown, April L Young, Ariel Cruz Figueroa, Becky Williamson, Bill Tacket, Jr, Billi Jom Johnson, Boun M Xiong, Bradley A Servais, Brian E Thompson, Brian L Szcyubialka, Brian R Yaun, Carolyn A Warren, Catherine M Vanderhoef, Chantel D Stennis, Charles R Cote, RIC, Christi L Bellmore, Christina A Castineyra, Christine M Erickson, Cindy Gunnarson, Clara E Santiago, Connie L Richard, Constance L Richard, Corey K Reno, Courtney R Ingalsbe, Courtney R Tiegs, Dacia E Quick, Dale A Nyberg, Darlene L Krieger, David B Wieneke, David J Ward, David P Moorhead, Demetria L Lueneburg, Denise L Burosh, Diane Kretschmer, Diane T Reindl, Dianna C Sonnenburg, Douglas J Snyder, Douglas R Nelson, Douglas W Atkins, Edward A Fabiano, Edward M James, Elias H Wachter, Elizabeth B Griffin, Elizabeth P Mayer, Ellen C Weisensel, Emily S Mcgann, Eric A Breselow, Eric T Huebler, Esther A Ofori, Fannie M Harrell, Frank S Sedzielarz, Gale L Glinecki, Gerald E Scholze, Gloria A Milster, Grant M Ruis, Gregory R Brinsley, Gregory W Smith, Howard A Burmester, Humera T Khan, Ivan E Reyes, J Benedict, Jacob A Clark, Jacob W Reynolds, Jake T Lane, James K Ireland, Jamie R Thompson, Jane E Nelson, Janis R Armedoriz, Jasjeet K Sekhon, Jean M Bosenbecker, Jean M Trimbo, Jeanne M Morris, Jeffery A Hangartner, Jeffrey A Hangarfner, Jeffry A Bernhardt, Jennifer A Jones, Jennifer Guttuso, Jeremy L Tri, Jessica L Barr, Joel D Hustedt, John A Iwen, John E Emmert, John Misock, John P Hermann, Jon C Polzine, Julia A Avery, Justin A Boyd, Justin J Jafferis, Kailas Nagaraj, Karen M Gasperic, Karen M Labounty, Karla J Youngberg, Katherine A Clarke Girolamo, Kathryn M Mogen, Kathy Ac Girolamo, Keith C Rindahl, Kellie L Thommes, RN, Kellie L Westerbuhr, Kenneth A Libertoski, Kevin L Torgerson, Kia L Copeland, Kimberly Lewandowski Walker, Kimberly W Destromp, Krista K Petersen, Kristy E Zuroski, Larae M Koopman, Lauren E Merz, Lauren E Sanger, Lauren M Lilly, PhD, LCDR Ismael Olvera, IV, Lee Terry Moore, Leon R Stratman, Leonardm, Liliya V Bubiy, Liming Zhang, Linda V Weyer, Lisa M Lopez, Mada A Tautges, Marc A Jackson, Jr, Maria E Treadwell, Mary M Finn, Mary R Chestolowski, Maryann Ruff, Melanie C Voges, Melissa D Kalik, Melissa I Michurski, Melissa J Holz, Michael E Cimaglio, Michele L Glendenning, Michelle J Glembin, Mohammed H Adam, Nicholas J Dubrovin, Nicholas S Vasilakes, Nicholas T Domer, Nicole C Shokatz, Norman K Starks, Pamela A Kuist, Patrick J Campbell, Peter M Trunk, Peter T Erlandson, Rafael A Kaup, Rebecca L Caulfield, Rebecca L Keller, Rebecca L Mullikin, Richard Jay Tucker, RS, Richard M Willey, Richard W Koller, Robert H Claflin, Robert J Waldorf, Robert M Tillman, Ronald R Ruff, Ross J Grigsby, Rostislav Servetnyk, Ryan A Bennett, Sandra A Hughes, Sandra D Wilson, Sandra Sejdinovic, Sarah A Palmer, Sarah Nwandiuko, Scott A Golladay, Scott B Laufenberg, Scott L Schenian, Shalonda C Clifford, Sharon K Thoma, PharmD, Shaun M Olson, Soyinka S Eneng, Steven A Skaar, Susan M Miller, Susan M North, Suzanne M Crotty, Tanya L Keigley, Tara C Singh, Tara M Carolfi, Tara M Humfeld, Tenzin Jangchup, Terrance L Scheiber, Theresa C Klaman, Theresa M Spicer, Thomas S Donaldson, Thomas W Garvin, Traci C Kelm, Travis S Bradley, Tyson J Eldridge Stedman, Wendy A Good, William E Keer, William P Fournier, Zachary P Wachlarowicz

Jesse P Romenesko's Documents

Publish Date Document Type Title
July, 2016 FDA 483 Chemrite Copac, Inc. - Form 483, 2016-07-15
March, 2016 FDA 483 Chemrite Copac, Inc. - Form 483, 2016-03-24
August, 2006 FDA 483 Schwabe North America, Inc. - Form 483, 2006-08-18
March, 2003 FDA 483 Athea Laboratories Inc - Form 483, 2003-03-05
August, 2018 FDA 483 Associated Milk Producers Inc. - Form 483, 2018-08-10
March, 2017 EIR West Duluth Distribution Company dba CHK Nutrition - EIR, 2017-03-30
November, 2011 FDA 483 Tufco - Form 483, 2011-11-01
February, 2004 EIR TMV Feed & Supply LLP - EIR, 2004-02-20
March, 2017 FDA 483 West Duluth Distribution Company dba CHK Nutrition - Form 483, 2017-03-30
July, 2006 FDA 483 Unlimited Futures, Inc. - Form 483, 2006-07-13
August, 2009 EIR Top Brass, Inc. - EIR, 2009-08-07
July, 2016 FDA 483 Response Chemrite Copac, Inc. - Form 483R, 2016-08-04
March, 2003 EIR Athea Laboratories Inc - EIR, 2003-03-05
April, 2009 FDA 483 ProActive Solutions USA LLC - Form 483, 2009-04-08
March, 2019 EIR Didion Milling, Inc. - EIR, 2019-03-05
May, 2017 FDA 483 Accelerated Analytical - Form 483, 2017-05-12
May, 2015 FDA 483 Tufco - Form 483, 2015-05-13
December, 2010 FDA 483 Schwabe North America, Inc. - Form 483, 2010-12-03
October, 2015 FDA 483 Rockline Industries - Form 483, 2015-10-06
September, 2013 FDA 483 National Packaging Services Corporation - Form 483, 2013-09-20
April, 2022 FDA 483 Perrigo Wisconsin, LLC - Form 483, 2022-04-14
September, 2023 FDA 483 Nature's Pharmacy, LLC - Form 483, 2023-09-20
September, 2011 FDA 483 NORTHERN LABS, INC. - Form 483, 2011-09-23
May, 2017 FDA 483 Response Accelerated Analytical - Form 483R, 2017-05-25
October, 2015 EIR Rockline Industries - EIR, 2015-10-06
November, 2005 FDA 483 Biomat USA Inc. DBA Talecris Plasma Resources - Form 483, 2005-11-28
May, 2015 EIR Kleen Test Products Corporation - EIR, 2015-05-20
August, 2002 EIR International Bio Resources LLC - EIR, 2002-08-14
July, 2004 EIR Land O'Lakes Inc. - EIR, 2004-07-26
June, 2016 EIR Top Brass, Inc. - EIR, 2016-06-02
May, 2024 FDA 483 WAKKER DAIRY FARM LLC - Form 483, 2024-05-03
May, 2023 FDA 483 Irish Acres, LLC - Form 483, 2023-05-11

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