FDA Investigator Hyung Yul Lee

Hyung Yul Lee has conducted inspections on 4 sites in 3 countries as of 03 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
4
Last Inspection Date:
03 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Korea (Republic of), United States of America, India
FDA Investigators that have inspected at least one site in common with Hyung Yul Lee:
Aditi S Thakur, Alan L Truong, Alicia M Mozzachio, Andrew J Barrowcliff, Arsen Karapetyan, Ashar P Parikh, Bijoy Panicker, Bo Chi, PhD, Charles Yuanchia Kuo, PhD, Chiang Syin, PhD, Concepcion Cruz, Jr, Cristina Ausin Moreno, PhD, Daniel J Roberts, Deborah Schmiel, PhD, Diane L Raccasi, Dogbeda F Mackenzie, Dr. Ralph M Bernstein, PhD, Eboni S Funderburk, Edwin Jao, Emilie E Kahn, Esther C Broner, PhD, Hao Kiet D Phan, Haoheng Yan, PhD, Jacek Cieslak, PhD, Jacob G Lutz, James A Lane, Jeanne Fringer, PhD, Jeffrey D Meng, Jeffrey P Raimondi, Jon P Antoniou, Joslyn K Brunelle, PhD, Junho Pak, Justin A Boyd, Kristin M Abaonza, Kurt A Brorson, PhD, Lakshmi Narasimhan, PhD, Laurel A Beer, LCDR Sean Byrd, Leslie Arivera Rosado, PhD, Logan T Williams, Lucila B Nwatu, Madushini Dharmasena, PhD, Maria Cruz Fisher, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marion Michaelis, Massod Rahimi, PhD, Matthew B Casale, Meisha R Sampson, Meisha Waters, Michael Shanks, MS, Michele L Forster, PhD, Michele Perry Williams, Monica Markovski, PhD, Muna Algharibeh, Nicholas L Paulin, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Patrick J Lynch, Peter Adams, PhD, Phillip Angart, PhD, Prabhu P Raju, Rabia Ballica, PhD, Rafeeq A Habeeb, Reyes Candau Chacon, PhD, Richard Ledwidge (nmi), PhD, Riley C Myers, PhD, Robert Barbosa, Robert M Barbosa, Saleem A Akhtar, Sandra A Boyd, Sarah Arden, Sarah Kennett, PhD, Sargum C Sood, Scott N Lim, Scott R Nichols, PhD, Sneha S Patel, Steven Fong, MS, PhD, Stuart W Russell, Thuy T Nguyen, LCDR, Timothy J Schmidt, Vaishali J Patel, Virginia Carroll, PhD, Viviana Matta, Wayne E Seifert, Wendy G Tan, PhD, Yanming An, PhD, Yuan Chia Kuo, Yun Wu, PhD, Zhong Li, PhD

Hyung Yul Lee's Documents

Publish Date Document Type Title
September, 2023 FDA 483 Samsung Biologics Co., Ltd. - Form 483, 2023-09-01
May, 2023 FDA 483 Catalent Indiana, LLC - Form 483, 2023-05-12

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