FDA Investigator Kelly Doremus
Kelly Doremus has conducted inspections on 121 sites in 3 countries as of 20 Mar 2014. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
121
Last Inspection Date:
20 Mar 2014
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America,
Brazil,
Argentina
FDA Investigators that have inspected at least one site in common with Kelly Doremus:
Alberto A Viciedo,
Allen Lou,
Amy M Cramer,
Amy Wyan Mai,
Ana S Cabrera,
Andrew J Molesky,
Anthony M Criscuolo, Jr,
Barbara J Maulfair,
Barbara Jwilimczyk Macri,
Cary Greene,
Charisse K Green,
Charles J Chacko,
Charlotte P Chang,
Christina N Maurino,
Craig W Swanson,
Crystal A Harlan,
Daniel W Johnson,
David H Smith,
Dena M Elimam,
Dhaval H Patel,
Diane B Radice,
Donyel M Jones,
Doreen P Canetti,
Doreen P Gubbay,
Edward D Mcdonald,
Edward O'shaughnessy,
Emmanuel Jramos Maldonado,
Eric J Cunningham,
Eric Rothschild,
Frank J Marciniak,
Gabriel Feng,
Gale L Glinecki,
Gianine E Delade,
Gianine E Tompkins,
Helen B Ricalde,
Helen Verdel,
Jacqueline A O'shaughnessy, PhD,
Jananiga Vanniyasingam,
Jason M Sluzynski,
Jennifer Macmillan,
Jessica M Monteiro,
Jill M Sooter,
Jogy George,
Jose V Obando,
Joseph F Mcginnis, RPh,
Joseph H Procopio, Jr,
Joseph S Fanelli,
Karen E D'orazio,
Kazi Rafiquzzaman,
Keith M Reilly,
Kelli F Dobilas,
Kelly I Anderson,
Kerry A Kurdilla,
Kinh Q Mac,
Kris K Moore,
Kristen E Rescigno,
Krystal O Ogunremi,
Kwong P Lee,
Kyle D Covill,
Laishan L Lam,
Lata C Mathew, PhD,
Lauren L Vajo,
Lawrence R Johnson,
Li Li,
Liatte Kreuger, PharmD,
Lisa B Hall,
LT Colin E Tack, BSE,
Marcelo O Mangalindan, Jr,
Marjorie D Schultz,
Matthew W Kyle,
Melba Trivera Clavell,
Melissa A Freeman,
Melissa B Libby,
Meredith L Sheridan,
Miguel Gmanzano Maldonado,
Nicholas E Squillante,
Nicholas J Morici,
Nikki S Ramirez,
Paterson,
Randolph Campos Santiago,
Raymond L Cheung,
Remache,
Richard D Manney,
Robert G Ruff,
Rodrigo Vilchez,
Saleem A Akhtar,
Sandra Kershaw,
Schultz,
Sherri J Liu,
Shreya Shah,
Sinai I Davis,
Stephanie T Durso,
Stephen J Mottola,
Steven M Weinman,
Susan M Halsted,
Tania E Vizcaino,
Tara G Bizjak,
Tara K Carmody,
Teigan M Mule,
Tonia F Bernard,
Tressa T Lewis,
Valerie C Reed,
Wayne J Meyer,
William J Muszynski,
William R Chang,
William V Thompson,
Willy A Orantes,
Zakaria I Ganiyu
Kelly Doremus's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| June, 2009 | FDA 483 | D.M. Davis Incorporated - Form 483, 2009-06-09 |
| September, 2012 | FDA 483 Response | N.V.E. Pharmaceuticals, Inc. - Form 483R, 2013-01-15 |
| September, 2010 | EIR | Queseria Chipilo, Inc. - EIR, 2010-09-23 |
| April, 2009 | EIR | Maquet Cardiovascular, LLC - EIR, 2009-04-17 |
| April, 2009 | FDA 483 | Maquet Cardiovascular, LLC - Form 483, 2009-04-17 |
| August, 2010 | EIR | Queseria Chipilo, Inc. - EIR, 2010-08-18 |
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