FDA Investigator Nicholas L Paulin

Nicholas L Paulin has inspections in 14 countries as of 19 Oct 2023. Nicholas L Paulin has collaborated with a combinined 8137 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
202
Last Inspection Date:
19 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Germany, United Kingdom of Great Britain and Northern Ireland, Canada, Singapore, Czechia, New Zealand, Italy, Sweden, Switzerland, Spain, Belgium, Finland, Australia
Co-Investigator(s):
Ademola O Daramola, Alan Escalona, Alan M Barker, Alan P Kurtzberg, Alicia M Mozzachio, Allison C Hunter, Allison E Sincek, Amanda M Dunneback, Andrew I Carr, Andrew J Barrowcliff, Andrew J Barroweliff, Andrew J Lang, Andrew M Kupper, Andria L Kuhlman, Angela E Glenn, Anita R Michael, Ann L Demarco, Anna Lazar, Anna M Brannen, Annemarie H Cochran, Annemarie Kleiza, Anthony R Petriella, Arie R Dyk, Arsen Karapetyan, Art O Czabaniuk, Azza Talaat, Babatunde D Babalola, Bailey A Uetrecht, Barbara Janine Breithaupt, Barbara M Frazier, Benjamin D Shuler, Benjamin J Dastoli, Benjamin J Smith, Bernard P Heidt, Bernice F Hirsch, Bethany L Subel, Bonita S Chester, Brenda C Hamilton, Brenda W Uratani, PhD, Brian D Rogers, Brian P Henderickson, Brian P Hendrickson, Bruce H Mccullough, Bryan J Love, Bryce A Hammer, Burnell M Henry, Byeongtaek Oh, Carl A Huffman, III, Carla J Lundi, Carlos Hruiz Nunez, Cassandra L Abellard, Cassandra L Winters, CDR Rochelle B Young, RPh, MSA, Charisse K Green, Charles C Conn, III, Charles Cconn Lii, Charles L Larson, Charles R Cote, RIC, Chelsea J Falkowski, Cherrie A Zachary, Chiaochun J Wang, Chris A Sack, Christian L Witkovskie, Christina Capacci Daniel, PhD, Christina L Bigham, Christine E Kelley, Christine I Shaw, Christine W Twohy, Christopher D Leach, Christopher T Middendorf, Clinton D Priestley, Constance Y Fears, Constantin Y Philopoulos, Courtney E Hillier, Craig P Seaborn, Craig T Rybus, Cristina Ausin Moreno, PhD, Cristina Ausin Moreoo, PhD, Cynthia T Cain, D Yvette Barnett, Daisy E Ramos, Daniel J Lahar, Darrah, Darren S Brown, Darren S Morgan, Daryl A Dewoskin, David A Oluwo, David C Radle, David J Gomes, David J Hafner, David K Glasgow, David P Moorhead, David S Jackson, Dawn C Olenjack, Deborah M Trout, Dell S Moller, Dennis Cantellops Paite, Dennis R Downer, Deyaa Shaheen, Diane L Raccasi, Diane M Fresch, Diane R Mcdaniel, Dina K West, Djamila Harouaka, Doan T Nguyen, PharmD, Donna F Campbell, Dorathy M Eischen, Douglas C Kovacs, Dr. Carmelo Rosa, Dyvette Arline, Eboni S Funderburk, Edmund F Mrak, Jr, Edward R Kay, Edwin Jao, Elizabeth L Loreaux, Elizabeth Ll Edwards, Elizabeth P Kinsella, Emest F Bizjak, Emilie E Kahn, Emma A Nesbit, Emmanuel J Ramos, Eric E Joneson, Eric M Mueller, PharmD, Esther C Broner, PhD, Evan M Kupper, Farhana Khan, Felipe Rde Almeida, Felix Maldonado, Francis A Guidry, Freddy Ortiz Colon, Frederick M Fochner, Frederick M Lochner, Frederick Razzaghi, Gabriel E Muniz, Genevieve E Ghand, Geoffrey K Kilili, Gerard T Schneider, Gilbert J Heidenblut, Gina M Brackett, Green, Gretchen N Kilby, Gwyn G Dickinson, Hang N Guo, Heather A Mccauley, Helen Verdel, Holly J Rapier, Holly J Wilson, Holly L Miller, Hugh M Mcclure, II, Hyung Yul Lee, Ivis Lnegron Torres, James A Lane, James C Maclaughlin, James G Marsh, James I Giefer, James L Dunnie, Jr, James M Kewley, James Norman, James P Mcreavey, James R Evans, Janet L Bowen, Jason D Werne, Javier O Vega, Javonica F Penn, Javonica Penn, Jay T Wong, Jazmine N Still, Jeffrey A Sincek, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey W Shrifter, DPM, Jennifer L Gustavus, Jennifer L Jager, Jennifer L Watson, Jennifer M Heitz, Jeremy W Rotton, Jerry J Corwin, Jill R Loeliger, Jill R Raezer, Joanne M Schlossin, Jogy George, John D Jaworski, John E Russell, Jolanna A Norton, Jon P Antoniou, Jonathan A Ferguson, Joohi Castelvetere, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose Martinez, Jr, Jose R Hernandez, Joseph D Cooper, Joseph X Kaufman, Joshua P Wireman, Joshua S Hunt, Joslyn K Brunelle, PhD, Julie D Bringger, Justin A Hefferman, Karen M Cooper, Karen M Kondas, Karyn M Campbell, Katherine E Jacobitz, Kathleen D Culver, Kathryn J Mccarty, Katie L Korchinski, Keith J Jasukaitis, Keith J Mason, Kelley L Clark, Kelli Wilkinson, Kenneth E Felkley, Kenneth H Williams, Kerry Ann Latham, Kevin P Foley, Kham Phommachanh, Kimberly A Joseph, Kirk A Dymbrowski, Klein, Krista B Jones, Krista T Ferry, Kristen D Evans, Larry K Austin, Latorie S Jones, Laura E Garcia, Laureen M Geniusz, Lauren N Howard, Lauren N Smith, Lauren R Collins, Lawrence Harmon, Jr, LCDR Audra J Lenhart, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Sean Byrd, Lesley K Satterwhite, Leslie R Clark, Li Li, Lianji Jin, Liatte Kreuger, PharmD, Linda S Jozefiak, Linda Thai, Lindsey M Schwierjobann, Lindsey M Schwierjohann, Lisa B Orr, Lisa Hornback, Lisa J Joseph, Lisa J Renick, Lisa M Marko, Lisa R Hilliar, Lisa Shin, Logan T Williams, Lori A Carr, Lori A Lahmann, Lori S Lawless, LT Skip A Payne, LTJG Aaron B Otis, Luckner Jean Marie, Luella J Rossi, Luis A Dasta, Lydia Irosas Marty, Malik S Qaiser, Maney P Sturgill, Mantai Z Mesmer, Margaret M Annes, Maria Cruz Fisher, Maria I Cruz Fisher, Marianne Allen, Maribeth G Niesen, Marie A Fadden, Marie F Morin, Mark E Parmon, Mark Loh, Mark P Loh, Mark R Mcclain, Martha Sullivan Myrick, Mary B Sheets, Mary E Storch, Matt D Suedkamp, Matthew B Casale, Matthew D Soedkamp, Matthew H Pitts, Megan A Haggerty, Mei Chiung J Huang, Meisha R Sampson, Meisha Waters, Melanie N Parsons, Melissa T Roy, Meredith M Cobb, Michael Campbell, Michael D Thatcher, Michael E Campbell, Michael E Clark, Michael E Maselli, Michael P Sheehan, Michael R Goga, Michael R Klapal, Michael Serrano, Michael Shanks, MS, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle L Jones, Miguel A Martinez, Mikhail V Ovanesov, PhD, Mindy M Chou, Moseley Fulcher, Mra Davism, Mra Mcculloughj, Mra Munizn, Mra Narulaa, Muna Algharibeh, Muna Alghribeh, Nadeem Chandhry, Nadeem I Chaudhry, Nancy A Bellamy, Nancy F Scheraga, Nibin Varghese, MS, Nicholas J Presto, Nicholas Paulin, Niketa Patel, Nina Ni, Omotunde O Osunsanmi, Pamela A Kuist, Paranthaman Senthamaraikannan, Patricia A Borrusso, Patricia A Homola, Patricia H Dlugosz, Patrick W Mcafee, Patsy J Domingo, Paul A Bonneau, Paula A Trost, Peter C Chow, Philip S Woodward, Phillip M Pontikos, Pifer, Rabia Ballica, PhD, Rafael Nevarez Nieves, Ralph A Erickson, Ralph H Vocque, Rasha Bamieh, Raymond T Oji, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Regina T Brown, Renee N Easter, Richard E Needham, Richard H Penta, Richard J Friedman, Richard L Rutherford, Richard T Riggie, Richard W Berning, Robbie J Alleman, Robert Barbosa, Robert D Tollefsen, Robert G Taylor, Robert J Ham, Robert M Barbosa, Robert Rodriguez, Robert W Hudson, Robert W Jennings, Rochelle L Cross, Rohn R Robertson, Rosanna M Goodrich, Rose M Ashley, Rose Xu, Roy C Stephens, Russell J Glapion, Russell K Riley, Ryan J Benedict, Saied A Asbagh, Samuel A Hamblin, Sandra A Boyd, Sandra A Hughes, Sangeeta M Khurana, PhD, Sarah E Mcmullen, Sarah E Rhoades, Sargum C Sood, Sateesh Kum Sathigari, Satheesh Thomas, Scott R Nichols, PhD, Sean R Bryd, Sean R Marcsisin, Shankar L Saha, Shannon A Gregory, Shannon F Underwood, Sheri L Stephenson, Simone E Pitts, Sneha S Patel, State Agency, Stephen D Brown, Stephen J Kilker, Stephen J Rabe, Steven A Gonzales, Steven M Weinman, Steven P Eastham, Sunita Iyer, Susan F Laska, MS, Susan M Taylor, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Sydney S Choi, Tajah L Blackburn, Talmane J Fisher, Tamara M Kays, Tamil Arasu, PhD, Tara G Bizjak, Tarun D Mehta, Ted L Anderson, Temar Q Williams, Teresa K Kastner, Terri L Dodds, Theresa C Klaman, Thomas A Peter, Thomas C Woods, Thomas E Friel, Thomas J Arista, Thomas J Prigge, Thomas S Arista, Thomas W Nojek, Thunder N Dunkijacobs, Tiki J Dixon, Timothy J Schmidt, Tina M Pawlowski, Tonia F Bernard, Tonnie L Carter, Tracey L Harris, Tracey L Siebesma, Tracey L Taylor, Troy A Huffman, Twana R Chandler, Tyra S Wisecup, Ucheabuchi C Chudi Nwankwor, Unnee Ranjan, Vaishali J Patel, Vipulchandra N Dholakia, Viviana Matta, Vlada Matusovsky, Walden H Lee, Wayne E Seifert, Wen Ning Chan (Sally), Wendy G Tan, PhD, William D Tingley, William G Nelson, William J Leonard, William K Ducloux, Xikui Chen (nmi), PhD, Yanming An, PhD, Ying Zhang, Youmin Wang, Yumi J Hiramine, Yvette Mlacour Davis, Yvins Dezan, Yvonne C Mcknight, Zhigang Sun, PhD

Nicholas L Paulin's Documents

Publish Date Document Type Title
June, 2014 FDA 483 Response Ben Venue Laboratories Inc. - Form 483R, 2014-06-19
March, 2015 FDA 483 American Regent, Inc. - Form 483, 2015-03-19
February, 2018 EIR Patheon Pharmaceuticals Inc. - EIR, 2018-02-14
March, 2018 FDA 483 OAKWOOD LABORATORIES, L.L.C. - Form 483, 2018-03-29
May, 2016 FDA 483 Cambrex Karlskoga AB - Form 483, 2016-05-27
November, 2014 FDA 483 Response Smithfield BioScience, Inc. - Form 483R, 2014-11-24
March, 2009 FDA 483 Caudill Sprouting LLC. - Form 483, 2009-03-27
March, 2012 FDA 483 Xanodyne Pharmaceuticals Inc - Form 483, 2012-03-30
January, 2018 EIR Teva Women's Health LLC - EIR, 2018-01-26
March, 2010 EIR Patheon Pharmaceuticals Inc. - EIR, 2010-03-24
March, 2016 FDA 483 PuraCap Laboratories LLC - Form 483, 2016-03-17
March, 2014 FDA 483 Fermion Oy - Form 483, 2014-03-14
June, 2014 EIR Ben Venue Laboratories Inc. - EIR, 2014-06-06
April, 2010 FDA 483 KUTOL PRODUCTS COMPANY - Form 483, 2010-04-09
March, 2012 FDA 483 S.A.E.G. - Form 483, 2012-03-19
July, 2015 EIR Avantor Performance Materials, LLC - EIR, 2015-07-17
October, 2018 FDA 483 TMC Acquisitions LLC dba Tailor Made Compounding - Form 483, 2018-10-24
May, 2008 EIR TreeHouse Private Brands, Inc. - EIR, 2008-05-20
May, 2015 FDA 483 Navidea Biopharmaceuticals Inc - Form 483, 2015-05-21
May, 2010 EIR PakLab - EIR, 2010-05-04
February, 2018 FDA 483 Patheon Pharmaceuticals Inc. - Form 483, 2018-02-14
February, 2008 EIR Burnette Foods, Inc - EIR, 2008-02-15
January, 2018 FDA 483 Teva Women's Health LLC - Form 483, 2018-01-26
December, 2009 FDA 483 Resilience US, Inc. - Form 483, 2009-12-23
September, 2009 FDA 483 Ben Venue Laboratories Inc. - Form 483, 2009-09-17
May, 2014 EIR West-Ward Columbus Inc. - EIR, 2014-05-21
February, 2018 FDA 483 Response Patheon Pharmaceuticals Inc. - Form 483R, 2018-03-08
May, 2018 FDA 483 Catalent Indiana, LLC - Form 483, 2018-05-01
September, 2011 FDA 483 Pharmacia Hepar LLC - Form 483, 2011-09-08
May, 2016 FDA 483 American Regent, Inc. - Form 483, 2016-05-05
January, 2011 FDA 483 West-Ward Columbus Inc. - Form 483, 2011-01-20
November, 2014 FDA 483 Smithfield BioScience, Inc. - Form 483, 2014-11-14
June, 2014 EIR Alza Corporation - EIR, 2014-06-05
February, 2011 EIR Playtex Manufacturing Inc - EIR, 2011-02-23
July, 2015 FDA 483 Response Avantor Performance Materials, LLC - Form 483R, 2015-07-27
March, 2014 EIR Haupt Pharma Wuelfing GmbH - EIR, 2014-03-28
May, 2017 FDA 483 Pharmacy Associates, Inc. dba CompreCare Specialty Pharmacy - Form 483, 2017-05-24
October, 2016 EIR Xellia Pharmaceuticals USA LLC - EIR, 2016-10-13
January, 2016 FDA 483 Central Admixture Pharmacy Services Inc - Form 483, 2016-01-21
March, 2014 FDA 483 Response Haupt Pharma Wuelfing GmbH - Form 483R, 2014-04-14
May, 2018 EIR Catalent Indiana, LLC - EIR, 2018-05-01
March, 2016 EIR PuraCap Laboratories LLC - EIR, 2016-03-17
March, 2009 EIR Caudill Sprouting LLC. - EIR, 2009-03-27
July, 2015 FDA 483 Avantor Performance Materials, LLC - Form 483, 2015-07-17
April, 2017 FDA 483 Advanced Crystal Therapies - Form 483, 2017-04-25
May, 2015 EIR Navidea Biopharmaceuticals Inc - EIR, 2015-05-21
September, 2015 FDA 483 Laboratorios Lesvi S.L. - Form 483, 2015-09-18
June, 2014 FDA 483 Ben Venue Laboratories Inc. - Form 483, 2014-06-06
September, 2016 FDA 483 Cincinnati Specialty Pharmacy, LLC - Form 483, 2016-09-26
May, 2011 FDA 483 Ben Venue Laboratories Inc. - Form 483, 2011-05-25

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.

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