FDA Investigator James C Lee, PharmD
James C Lee, PharmD has conducted inspections on 50 sites in 1 countries as of 05 Jan 2017. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
50
Last Inspection Date:
05 Jan 2017
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with James C Lee, PharmD:
Alicia Gilbert,
Alla Dubrovsky,
Andrew B Slarve,
Andrew C Chang,
Andrew E Kay,
Andrew Tadros,
Anh M Lac,
Ann Marie Montemurro,
Ann Marie Schofield,
Anna L Marroquin,
Annie H Lam,
Ashar P Parikh,
Breena L D'ambrogi,
Brian R Henderson,
Bruce D Broidy,
Capri R Woolridge,
Carl Lee,
CDR Rochelle B Young, RPh, MSA,
Chloe Anne Leong,
Christian D Lynch (CDL),
Christopher R Czajka,
Damon A Growl,
Daniel J Roberts,
Daniel Lagasse,
Daniel Velasquez,
David A Lum,
David G Eng,
Edna J Hidalgo,
Elmina E Akwo,
Elodie X Tong Lin,
Emal Wahab,
Emmanuel O Kerry,
Eric J Heinze,
Helen B Ricalde,
Helen J Hamaoka,
Ingrid A Zambrana,
Ismael Garibay,
Jacqueline Mdiaz Albertini,
James C Yee,
James G Marsh,
Jane G Choi,
Jeanmaire Hryshko,
Jeanne A Young,
Jeffrey M Watson,
Jennifer Crumb,
Jennifer L Johnson,
Jennifer S King,
Jessica B Darneille,
Joan T Briones,
John A Gonzalez,
John A Liu,
John Cook,
Jolene S Hedgecock,
Joseph George,
Joseph Tibay,
Josephine Valdemoro Chavez,
Julie D Bringger,
Karen D Phung,
Karen J Bak,
Kenneth S Boehnen,
Kevin P Foley,
Kimiko G Casuga,
Lance Mde Souza, MBA,
LCDR Jennifer H Rhyu,
Lea Lakes,
Linda Linh N Adams,
Linda Thai,
Lourdes Andujar,
Lucila B Nwatu,
Lynda L Perry, PhD,
Mabel M Lee,
Macropolk,
Maida Henesian (NMI),
Makia P Dove,
Margo C Jones,
Maridali Deleon Torres,
Mariza M Jafary,
Mark E Chan,
Marshalette O Edwards,
Mary C Wall,
Megan E Kulas,
Mei Chiung Huang (Jo),
Melody M Ragasa Leong,
Mihaly S Ligmond,
Monique C Lo,
Nancy E Kirschbaum,
Nancy T Waites,
Nicole Yuen,
Omotunde O Osunsanmi,
Patrick E Gainer,
Paula A Trost,
Peter E Baker,
Phung,
Prabhu P Raju,
Quynh H Strandberg,
Ralph A Erickson,
Ravi S Harapanhalli,
Raymond T Oji,
Richard W Thornton,
Riley C Graham,
Robert Jennings,
Robles,
Roman T Drews, PhD,
Ronald P Boyce,
Rumany C Penn, PharmD,
Sabino S Camacho,
Samuel J Barone, III,
Sandra S Saniga,
Savannah E Samp,
Scott N Lim,
Sergio Chavez (NMI),
Simone E Pitts,
Siobhan A Gallagher,
Stephanie A Slater, MS,
Steven B Chiu,
Steven M Galvez,
Stuart Kim,
Susan M Jackson,
Terrence Gee,
Thomas N Adjabeng,
Timothy C Grome,
Travelle D Mason,
Uduak M Inokon,
Vi T Au,
Victoria L Morgan,
Vijaya L Simhadri,
Walden H Lee,
Wayne L Jefferson,
Wendy S Shenk,
William J Weis,
Zuben E Sauna, PhD
James C Lee, PharmD's Documents
Publish Date | Document Type | Title |
---|---|---|
December, 2016 | FDA 483 | Bayer HealthCare LLC - Form 483, 2016-12-13 |
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](/images/InspectorProfile.png)
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