FDA Investigator Christopher Downey, PhD

Christopher Downey, PhD has conducted inspections on 5 sites in 4 countries as of 06 Oct 2017. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
5
Last Inspection Date:
06 Oct 2017
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
Puerto Rico, United States of America, Germany, Denmark
FDA Investigators that have inspected at least one site in common with Christopher Downey, PhD:
Adaliz Santaliz Cruz, Aimee Cunningham, PhD, Alan A Rivera, Amy Devlin, PhD, Andrea George, PhD, Anh M Lac, Anissa M Cheung, Anita Narula, PhD, Ann L Demarco, Arie C Menachem, Arlene M Badillo, Ashley N Queen, PhD, Ashutosh Rao, PhD, Azza Talaat, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brenda P King, Brenda W Uratani, PhD, Brentley S Collins, Brian M Janelsins, PhD, Burnell M Henry, Calvin B Koerner, Charles Yuanchia Kuo, PhD, Christian D Lynch (CDL), Christina Capacci Daniel, PhD, Colleen Thomas, PhD, Concepcion Cruz, Jr, Dawn M Braswell, Deborah Schmiel, PhD, Dennis Cantellops Paite, Devaughn Edwards, Diane L Raccasi, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Dov H Pluznik, PhD, Dr. Ralph M Bernstein, PhD, Dr. Zhihao Qiu (Peter), PhD, Ekaterina Allen, Eliezar Ramos, Ellen P Madigan, Ephrem Hunde, PhD, Erika V Butler, Felix Maldonado, Gene D Arcy, Gunther Boekhoudt, PhD, Ivis L Negron, Jacek Cieslak, PhD, Jason F Chancey, Jee Chung, PhD, Jennifer Lalama, Jerri Baker, John D White, Jorge L Lajara, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose R Lopez, Jose Velez, Joyce A Rockwell, Julie D Bringger, Justine M Corson, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Kathleen R Jones, PhD, Kevin A Gonzalez, Kurt A Brorson, PhD, LCDR Debra Emerson, Leopold Kong, PhD, Leslie Arivera Rosado, PhD, Libia M Lugo, LT Rafael Gonzalez, Maria Gutierrez Lugo, PhD, Marian E Ramirez, Mariza M Jafary, Mark Brunswick, PhD, Martha T Olone, Mary E Storch, Mary Kaulee, Maxwell Van Tassell, PhD, Megan A Haggerty, Michael A Charles, Michael Shanks, MS, Michelle M Noe Varga, Michelle Yclark Stuart, Mihaly S Ligmond, Milos Dokmanovic, PhD, Milva E Melendez Perales, Monica Commerford, PhD, Monique C Lo, Mra Munizn, Mra V Millarw, Myriam M Sosa, Nailing Zhang, Nicholas Obiri, PhD, Nikolay Spiridonov, Noreen Muñiz, Nydia E Colon, Ogechi C Nna, Omotunde O Osunsanmi, Patricia F Hughes, PhD, Paul Z Balcer, Paula A Trost, Penny H Mccarver, Prabhu P Raju, Priscilla M Pastrana, Qing Joanna Zhou, PhD, Ramesh Potla, PhD, Ramon A Hernandez, Rashmi Rawat, PhD, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Reyes Candau Chacon, PhD, Richard H Penta, Richard Ledwidge (nmi), PhD, Richard W Berning, Richard W Thornton, Riley C Myers, PhD, Robert Darius, Robert J Martin, Robert Jennings, Rose Ashley, Sean R Marcsisin, Seneca D Toms, Seth A Mailhot, Simon Williams, PhD, Sonya M Edmonds, Stacey S Degarmo, Steven C Madzo, Steven Fong, MS, PhD, Thomas J Arista, Thuy T Nguyen, LCDR, Timothy Wadkin, PhD, Veronica Fuentes, MS, Victor J Gangi, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Walter N Lange, Wayne E Seifert, Wendy G Tan, PhD, Xianghong Jing (Emily), PhD, Xiaoxiao Pan, PhD, Xuhong Li, Yanming An, PhD, Yehualashet A Gessesse, Yuan Chia Kuo, Yun Wu, PhD, Zachary L Stamm, Zerita White, Zhenzhen Liu, PhD, Zhong Li, PhD, Ziyang Su, PhD

Christopher Downey, PhD's Documents

Publish Date Document Type Title
January, 2016 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2016-01-22
July, 2016 FDA 483 FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2016-07-08
May, 2015 FDA 483 FUJIFILM Diosynth Biotechnologies U.S.A., Inc - Form 483, 2015-05-01

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