FDA Investigator J David Doleski
J David Doleski has conducted inspections on 14 sites in 9 countries as of 26 Jul 2012. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
14
Last Inspection Date:
26 Jul 2012
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
Canada,
United States of America,
Belgium,
Italy,
Netherlands,
United Kingdom of Great Britain and Northern Ireland,
Singapore,
Germany,
Israel
FDA Investigators that have inspected at least one site in common with J David Doleski:
Alexey Khrenov, PhD,
Alla Kachko, PhD,
Althea A Williams,
Ana S Cabrera,
Anastasia I Offordile,
Angela K Shen,
Anissa M Cheung,
Anita Narula, PhD,
Anita R Michael,
Ann L Demarco,
Ann Marie Montemurro,
Ann Marie Schofield,
Annemarie Bodnar,
Anthony F Lorenzo,
Arduino Frankovic,
Arie C Menachem,
Audrey Thereset Uy,
Brentley S Collins,
Brian S Keefer,
Burnell M Henry,
Byungja E Marciante,
Cassandra Overking,
CDR Donald Ertel,
CDR Jeremy L Wally, PhD,
Chad R Burger,
Chao Ming Tsai,
Christian D Lynch (CDL),
Christina J Sauder, PhD,
Christopher J Adams,
Craig D Zagata,
Creighton T Tuzon,
Cynthia Jim, CSO,
Darla J Christopher,
Dave Hafner,
David Doleski,
David J Hafner,
David S Cho, PhD,
Dawn L Wydner,
Debra J Bennett,
Debra L Pagano,
Destry M Sillivan,
Donald C Obenhuber, PhD,
Dr. Zhihao Qiu (Peter), PhD,
Eileen A Liu,
Ellen Huang,
Erika V Butler,
Ewa Marszal, PhD,
Felice D'agnillo, PhD,
Gene D Arcy,
Hala L Selby,
Haruhiko Murata,
Helen B Ricalde,
Hyesuk Kong,
Jacqueline Mdiaz Albertini,
James L Kenney, DSc,
James M Mason,
James M Simpson,
James R Evans,
James T Mccoy,
Jean M Kelahan,
Jennifer Macmillan,
Joan A Loreng,
Joan Adamo,
Joanne M Hajoway,
Joanne Pryzbylik,
John D Finkbohner, PhD,
John F Cipollo,
John M Mcinnis,
John M Mclnnis,
Joseph George,
Joshua J Silvestri,
Jude C Dikes,
Julianne C Mccullough,
Julie D Bringger,
Junho Pak,
Karyn M Campbell,
Kathleen B Mihalik,
Kathryn Carbone, MD,
Kelly I Anderson,
Kelly N Kerr,
Kenneth M Gordon,
Kevin P Foley,
Kimberly M Bigler,
Kristen D Evans,
Laurel A Beer,
Laurie P Norwood,
LCDR Debra Emerson,
LCDR Margaret Edi Gennaro,
Lewis K Antwi,
Linda Thai,
Lisa M Bellows,
Lisa M Feola,
Lixin Xu, MD, PhD,
Lori S Lawless,
LT John M Mastalski,
Madushini Dharmasena, PhD,
Marc S Neubauer,
Marian E Major, PhD,
Marion Michaelis,
Mariza M Jafary,
Mark A Elengold,
Mark I Schwartz,
Martha O'lone,
Martha T Olone,
Mary T Carden,
Meihong Liu,
Michael C Kennedy, PhD,
Michael Curbarg,
Michael Gurbarg,
Mihaly S Ligmond,
Nawab A Siddiqui,
Nicholas Obiri, PhD,
Nicole K Trudel,
Olga Simakova, PhD,
Omotunde O Osunsanmi,
Pankaj H Amin,
Patricia A Morrow,
Paul A Bonneau,
Paula A Trost,
Prabhu P Raju,
Prajakta A Varadkar,
Priscilla M Pastrana,
Qiao Y Bobo,
Ramon E Martinez,
Randa Melhem, PhD,
Rebecca K Olin,
Regina Gibson Melton,
Richard D Manney,
Robert B Shibuya, MD,
Robert D Tollefsen,
Robert Jennings,
Robin Levis, PhD,
Roger F Zabinski,
Rona A Leblanc, PhD,
Ronald T Nowalk,
Rose Ashley,
Santos E Camara,
Sarah Forney,
Sarah Johnson, PhD,
Scott E Norris,
Scott T Ballard,
Seneca D Toms,
Sheila Dreher Lesnick,
Sheryl A Kochman,
Shuang Tang,
Sidney B Priesmeyer,
Simone E Pitts,
Stephanie Mangigian, MS/OSH, RN,
Stephen D Brown,
Steven A Rubin,
Steven P Donald,
Susan F Laska, MS,
Susan M Jackson,
Susan Yu,
Tammy L Chavis,
Teresita C Mercado,
Thomas E Friel,
Tina S Roecklein,
Travis S Bradley,
Troy C Quander,
Viviana Matta,
Vlada Matusovsky,
Wei Wang, PhD,
Xiao Wang,
Yanming An, PhD,
Yiping Jia
J David Doleski's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| August, 2012 | FDA 483 | LONZA BIOLOGICS TUAS PTE. LTD. - Form 483, 2012-08-03 |
| November, 2007 | EIR | CAF-DAF scrl - EIR, 2008-10-10 |
| February, 2010 | FDA 483 | Kamada - Production Plant - Form 483, 2010-02-11 |
| December, 2007 | FDA 483 | Prothya Biosolutions Netherlands B.V. - Form 483, 2007-12-07 |
| November, 2007 | FDA 483 | CAF-DAF scrl - Form 483, 2007-12-07 |
| November, 2007 | FDA 483 Response | CAF-DAF scrl - Form 483R, 2007-11-29 |
| December, 2007 | EIR | Prothya Biosolutions Netherlands B.V. - EIR, 2007-12-07 |
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