FDA Investigator Krystal O Ogunremi
Krystal O Ogunremi has conducted inspections on 59 sites in 3 countries as of 22 Oct 2013. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
59
Last Inspection Date:
22 Oct 2013
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America,
South Africa,
Brazil
FDA Investigators that have inspected at least one site in common with Krystal O Ogunremi:
Alberto A Viciedo,
Allen Lou,
Amy L Singer,
Amy M Cramer,
Anastasia I Onuorah,
Andrea A Branche,
Anthony J Donato,
Anthony M Criscuolo, Jr,
Anthony W Thomas,
Barbara J Maulfair,
Barbara Jwilimczyk Macri,
Benjamin Bustamante,
Byungja E Marciante,
Cara M Minelli,
Cary Greene,
Celia L Hutchinstein,
Charlotte P Chang,
Cheryl J Legrand,
Christina N Maurino,
Craig W Swanson,
Daniel W Johnson,
David H Smith,
Dawn L Wydner,
Deborah B Nixon,
Denise M Visco, Investigator,
Dhaval H Patel,
Diane B Radice,
Dorothy J Denes,
Douglas C Kovacs,
Dr. Gopa Biswas, PhD,
Eric J Cunningham,
Eric Rothschild,
Frederick F Razzaghi,
Gianine E Tompkins,
Guerlain Ulysse,
Helen Verdel,
Jean M Kelahan,
Jessica M Monteiro,
Jogy George,
John P Sakowski,
Jonee J Mearns,
Joseph Duca,
Joseph F Mcginnis, RPh,
Julianna M Chedid,
Justin H Price,
Justine Tomasso,
Karen E D'orazio,
Karen F Tomaziefski,
Keith M Reilly,
Kelly Doremus,
Kerry A Kurdilla,
Kimberly A Coward,
Laishan L Lam,
Lawrence R Johnson,
Li Li,
Liatte Kreuger, PharmD,
Lisa B Hall,
Luella J Rossi,
Marcelo O Mangalindan, Jr,
Marjorie D Schultz,
Melba Trivera Clavell,
Melissa B Libby,
Michael F Skelly, PhD,
Michael Serrano,
Miguel Gmanzano Maldonado,
Nancy F Scheraga,
Nilufer M Tampal, PhD,
Nina Yang,
Pasquale L Leone,
Peter R Lenahan,
Phillip O Mathis,
Rabin N Ghoshal,
Remache,
Richard D Manney,
Rodrigo Vilchez,
Rose Ljean Mary,
Sarah Forney,
Schultz,
Sherri J Liu,
Shirley S Wen,
Sinai I Davis,
Susan M Halsted,
Tara G Bizjak,
Teigan M Mule,
Tonia F Bernard,
Tressa T Lewis,
Unnee Ranjan,
Valerie C Reed,
Yasmin B Rios
Krystal O Ogunremi's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| December, 2010 | EIR | Concordia Clinical Research (IRB) - EIR, 2010-12-30 |
| September, 2012 | FDA 483 | Celgene Corporation - Form 483, 2012-09-12 |
| July, 2012 | FDA 483 | David S. Siegel, M.D. - Form 483, 2012-07-25 |
| January, 2012 | EIR | David S. Siegel, M.D. - EIR, 2012-01-27 |
| December, 2010 | FDA 483 Response | Concordia Clinical Research (IRB) - Form 483R, 2011-01-13 |
| June, 2013 | EIR | Merck Sharp & Dohme - EIR, 2013-06-13 |
| July, 2009 | FDA 483 | Omega Packaging Corporation - Form 483, 2009-07-14 |
| December, 2010 | FDA 483 | Concordia Clinical Research (IRB) - Form 483, 2010-12-30 |
| May, 2011 | FDA 483 | Merck & Co., Inc. - Form 483, 2011-05-06 |
| July, 2012 | EIR | David S. Siegel, M.D. - EIR, 2012-07-25 |
| September, 2012 | EIR | Celgene Corporation - EIR, 2012-09-12 |
| January, 2012 | FDA 483 | David S. Siegel, M.D. - Form 483, 2012-01-27 |
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