FDA Investigator Kristen Nickens, PhD

Kristen Nickens, PhD has conducted inspections on 3 sites in 2 countries as of 25 Apr 2022. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
3
Last Inspection Date:
25 Apr 2022
Investigator Role:
FDA Investigation Participant
Redica ID:
100000063
Countries of Inspections:
India, United States of America
FDA Investigators that have inspected at least one site in common with Kristen Nickens, PhD:
Amanda L Fyles, Arsen Karapetyan, Bijoy Panicker, Bo Chi, PhD, Bryan A Galvez, Christopher R Czajka, Davinna Ligons, PhD, Diane L Raccasi, Dr. Barbara D Paul, PhD, Dr. Jun Liu, PhD, Dr. Ralph M Bernstein, PhD, Eileen A Liu, Eric Hales, PhD, Frances Namuswe, PhD, Ian L Mcwilliams, Joel D Martinez, Lakshmi Narasimhan, PhD, Laura Fontan, MS, Laurie Nelson, Linda F Murphy, Lindsey Brown, PhD, Maria Gutierrez Lugo, PhD, Merry Christie, PhD, Michael Shanks, MS, Muralidhara B Gavini, PhD, Regina T Brown, Reyes Candau Chacon, PhD, S Lori Brown, PhD MPH, Sandra A Hughes, Sarah Kennett, PhD, Scott A Golladay, Thuy T Nguyen, LCDR, Yi Wang, PhD, Yun Wu, PhD, Zhong Li, PhD

Kristen Nickens, PhD's Documents

Publish Date Document Type Title
May, 2022 FDA 483 Tanvex BioPharma USA, Inc - Form 483, 2022-05-04
April, 2017 FDA 483 Biocon Biologics Limited - Form 483, 2017-04-07
March, 2020 FDA 483 Takeda Pharmaceuticals U.S.A., Inc. - Form 483, 2020-03-18
June, 2024 FDA 483 AstraZeneca Pharmaceuticals LP - Form 483, 2024-06-07

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