FDA Investigator Cynthia L Kelley
Cynthia L Kelley has conducted inspections on 3 sites in 3 countries as of 12 Dec 2001. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
3
Last Inspection Date:
12 Dec 2001
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
Germany,
Japan,
United States of America
FDA Investigators that have inspected at least one site in common with Cynthia L Kelley:
Alan L Truong,
Anissa M Cheung,
Ann Marie Montemurro,
Ann Marie Schofield,
Brentley S Collins,
Bruce D Meade,
Burnell M Henry,
CDR Donald Ertel,
Christian D Lynch (CDL),
Christine A Harman, PhD,
Cynthia Jim, CSO,
David E Bailey,
Deborah M Trout,
Dmitriy V Volokhov, PhD,
Dr. Willie F Vann, PhD,
Eliezar Ramos,
Ellen Huang,
Gene D Arcy,
Helen B Ricalde,
Holly Brevig,
Jacqueline Mdiaz Albertini,
Jean Lhu Primmer,
Jennifer L Bridgewater,
Joan Johnson,
John F Cipollo,
Julie D Bringger,
Justin A Boyd,
Kirsten L Vadheim, PhD,
Laurie P Norwood,
Leslie D Wagner,
Linda R Kuchenthal,
Linda Thai,
Lisa M Parsons,
Lisa P Oakes,
Marion Michaelis,
Marsha W Major,
Michele L Forster, PhD,
Mihaly S Ligmond,
Myra K Casey,
Omotunde O Osunsanmi,
Pankaj H Amin,
Patsy J Domingo,
Paula A Trost,
Prabhu P Raju,
Richard W Thornton,
Robert D Tollefsen,
Robert Jennings,
Robin Levis, PhD,
Rose Ashley,
Steven C Derrick,
Susan M Jackson,
Thai D Truong,
Unnee Ranjan,
William D Tingley
Cynthia L Kelley's Documents
Publish Date | Document Type | Title |
---|---|---|
December, 2001 | EIR | Emergent Biodefense Operations Lansing LLC - EIR, 2001-12-19 |
December, 2001 | FDA 483 | Emergent Biodefense Operations Lansing LLC - Form 483, 2001-12-19 |
September, 2000 | FDA 483 | GSK Vaccines GmbH - Form 483, 2000-09-01 |
September, 2001 | FDA 483 | Research Foundation for Microbial Diseases (Biken) - Form 483, 2001-09-19 |
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