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.
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