FDA Investigator Nealie C Newberger

Nealie C Newberger has inspections in 1 countries as of 23 Aug 2023. Nealie C Newberger has collaborated with a combinined 2385 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
42
Last Inspection Date:
23 Aug 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America
Co-Investigator(s):
Adetutu M Gidado, Aditi S Thakur, Alan R Condon, Alice C Silva, Allison A Aldridge, PhD, Alysia M Salonia, Amber G Wardwell, Amy C Jordan, Amy N Chen, Andrew M Barlow, Anne E Carpenter, Anthony C Warchut, Betsy C Galliher, Bo Chi, PhD, Brandy N Lepage, Brenda P King, Brenna L Macdowell, Byungja E Marciante, Calvin B Koerner, Carlos Chavez, Charles R Cote, RIC, Christine M Smith, Christopher Janik, Chunchun Zhang, Chunsheng Cai, PhD, Courtney N Long, Daniel L Zheng, Darin S Wiegers, Daryl A Dewoskin, Diane C Thibodeau, Diane M Prince, Dien N Nguyen, Dominic R Frasca, Donald C Obenhuber, PhD, Dr. Robert C Horan, MD, Edmund F Mrak, Jr, Edward J Janik, Eric C Schmitt, Erik W Koester, Erin I Keith, Gabrielle J Swain, Gary J Hagan, Hang N Guo, Helen B Ricalde, Jacek Cieslak, PhD, Jeffrey J Thibodeau, Jessica I Newman, John A Sciacchitano, John P Mistler, Johnna L Bleem, Jonah S Ufferfilge, Jonathan B Lewis, Jonathan G Matrisciano, Jose Acruz Gonzalez, Jose E Melendez, DDC, Jose O Hernandez, Jose Ohernandez Guzman, Julie D Bringger, Justine M Corson, Karen A Briggs, Karen Mcnabb Noon, Kenneth H Williams, Kent A Conforti, Kimberly M White, L Gnnmassimia Massimilla, PharmD, Laurie B Frazier, LCDR Debra Emerson, Lei Zhang, PhD, Leiyun Boone, PhD, Linda L Green, Lori M Newman, M Patriciaurphy Murphy, Margaret E Walsh, Margaret M Sands, Maria Joselopez Barragan, PhD, Mark R Mcclain, Matthew C Watson, Matthew D Silverman, Maya M Davis, Megan A Haggerty, Michael A Charles, Michael E Antaya, Michael P Anthony, Michael Shanks, MS, Michelle M Noe, Michelle Rfrazier Jessen, PhD, Michelle Y Clark Stuart, Mihaly S Ligmond, Mindy M Chou, Nina Yang, Paraluman S Leonin, Paul L Yeh, Paula M Laplant, Peter R Lenahan, Philip Kreiter, Ramon E Martinez, Rapti D Madurawe, Rebecca B Welch, Reyes Candau Chacon, PhD, Richard H Penta, Richard Ledwidge (nmi), PhD, Robert D Tollefsen, Robert J Martin, Samir C Gala, Sean R Marcsisin, Sherri N Rohlf, MD, Simone E Pitts, Stacey S Degarmo, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephen C Smith, Stephen R Souza, Steven Fong, MS, PhD, Susanne M Richardson, MSc RAC ELS, Suzanne M Healy, Tamara S Rosbury, Tanya R Syffrard, Thomas Cote, Thomas W Nerney, Victoria M Daddeo, Vidya B Pai, Wayne E Seifert, Wealie C Newberger, William Hallett, PhD, William J Leonard, Yetao Jin, PhD, Yvins Dezan, Zhihao Qiu (Peter), PhD, Ziyang Su, PhD

Nealie C Newberger's Documents

Publish Date Document Type Title
January, 2016 FDA 483 Response Aplicare Products, LLC - Form 483R, 2016-02-08
March, 2017 FDA 483 Reliant Compounded Solutions Monroe, LLC - Form 483, 2017-03-03
April, 2016 FDA 483 Denison Pharmaceuticals, LLC - Form 483, 2016-04-05
May, 2017 FDA 483 Ocular Therapeutix, Inc. - Form 483, 2017-05-04
April, 2017 FDA 483 Brookfield Medical/Surgical Supply, Inc. - Form 483, 2017-04-18
June, 2017 FDA 483 Brookfield Medical/Surgical Supply, Inc. - Form 483, 2017-06-28
June, 2017 FDA 483 Pfizer Laboratories Div Pfizer Inc - Form 483, 2017-06-07
January, 2016 EIR Aplicare Products, LLC - EIR, 2016-01-15
May, 2016 FDA 483 Milbar Laboratories, Inc. - Form 483, 2016-05-17
October, 2016 FDA 483 DCA, Inc. DBA Beacon Prescriptions - Form 483, 2016-10-25
September, 2017 FDA 483 AllerQuest LLC - Form 483, 2017-09-19
June, 2017 EIR Pfizer Laboratories Div Pfizer Inc - EIR, 2017-06-07
December, 2017 FDA 483 Milbar Laboratories, Inc. - Form 483, 2017-12-27
January, 2015 FDA 483 Airgas Usa, LLC - Form 483, 2015-01-14
July, 2017 EIR Alexion Pharmaceuticals, Inc. - EIR, 2017-07-21
September, 2014 FDA 483 Gregory Manufacturing, Inc. - Form 483, 2014-09-12
January, 2016 FDA 483 Aplicare Products, LLC - Form 483, 2016-01-15
August, 2016 FDA 483 Bayview Pharmacy, Inc. - Form 483, 2016-08-18
August, 2016 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2016-08-03
July, 2017 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2017-07-21
January, 2015 EIR Airgas Usa, LLC - EIR, 2015-01-14
April, 2016 FDA 483 Denison Pharmaceuticals, LLC - Form 483, 2016-04-05

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