FDA Investigator Jie He

Jie He has conducted inspections on 14 sites in 6 countries as of 12 Feb 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
14
Last Inspection Date:
12 Feb 2024
Investigator Role:
FDA Investigator
Redica ID:
100006964
Countries of Inspections:
United States of America, Austria, Canada, Taiwan, France, Sweden
FDA Investigators that have inspected at least one site in common with Jie He:
Adam R Cooke, Alan L Truong, Alice C Silva, Andrew C Chang, Andrey Sarafanov, PhD, Ann Marie Montemurro, Anna R Kwilas, Anthony F Lorenzo, Arie C Menachem, Binh T Nguyen, Bonita S Chester, Brentley S Collins, Burnell M Henry, Calvin B Koerner, Carl A Perez, CDR Thomas R Berry, PPh, Charles Yuanchia Kuo, PhD, Cynthia Jim, CSO, Daniel L Zheng, Deborah M Trout, Devaughn Edwards, Donald C Obenhuber, PhD, Dr. Gang Wang, PhD, Dr. Ralph M Bernstein, PhD, Dr. Zhihao Qiu (Peter), PhD, Eileen A Liu, Gilbert T Salud, Hai Lient Phung, Ibad U Khan, Jacqueline Mdiaz Albertini, James R Evans, Janet L Bowen, Jason F Chancey, Jennifer L Reed, Jianyang Wang, Joan A Loreng, John P Mistler, Jonathan G Matrisciano, Jose Acruz Gonzalez, Joseph F Owens, Joseph Kutze, PhD, Joshua P Wireman, Joyce A Rockwell, Justin A Boyd, Katherine D Adams, Kevin J Matthews, Kirsten L Vadheim, PhD, Kristen D Evans, Kristin M Abaonza, Laura I Salazar, PhD, Laura K Demaster, Laurel A Beer, LCDR Debra Emerson, Lei Zhang, PhD, Leiyun Boone, PhD, Lewis K Antwi, Libia M Lugo, Lois K Gross, Lu Deng, Marion Michaelis, Mary P Padgett, Michael C Kennedy, PhD, Michael J Vardon, Michael R Klapal, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Mindy M Chou, Nancy Kirschbaum, PhD, Nicole K Trudel, Obinna R Echeozo, Olga Simakova, PhD, Omotunde O Osunsanmi, Pankaj H Amin, Parul M Patel, Paula A Trost, Prabhu P Raju, Priscilla M Pastrana, Qiao Y Bobo, Rajiv R Srivastava, Randa Melhem, PhD, Rebecca K Olin, Rebecca Rodriguez, Robert Jennings, Roger F Zabinski, Ronit Jolles Mazor, Scott E Norris, Scott T Ballard, Seneca D Toms, Sharmila Shrestha, Sidney B Priesmeyer, Simone E Pitts, Sony Mathews, Susan M Jackson, Tamara M Casselman, Thai D Truong, Thuy T Nguyen, LCDR, Tracy R Ball, Viviana Matta, Wayne E Seifert, Wendy G Tan, PhD, Yonggang Wang, PhD, Yuan Chia Kuo, Ze Peng, Zhao Wang, PhD

Jie He's Documents

Publish Date Document Type Title
April, 2016 FDA 483 ADIMMUNE CORPORATION - Form 483, 2016-04-01
July, 2012 FDA 483 Octapharma AB - Form 483, 2012-07-30
January, 2023 FDA 483 Berkshire Sterile Manufacturing, Inc. - Form 483, 2023-01-20
July, 2024 FDA 483 Lonza Netherlands B.V. - Form 483, 2024-07-12

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