FDA Investigator Steven A Rubin
Steven A Rubin has conducted inspections on 7 sites in 4 countries as of 19 Jun 2017. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
7
Last Inspection Date:
19 Jun 2017
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United Kingdom of Great Britain and Northern Ireland,
United States of America,
Germany,
Australia
FDA Investigators that have inspected at least one site in common with Steven A Rubin:
Alla Kachko, PhD,
Anastasia I Offordile,
Angela K Shen,
Anissa M Cheung,
Anita R Michael,
Ann L Demarco,
Ann Marie Montemurro,
Ann Marie Schofield,
Anthony F Lorenzo,
Arthur S Williams, Jr,
Audrey Thereset Uy,
Brentley S Collins,
Brian S Keefer,
Burnell M Henry,
Carla J Lundi,
Cassandra Overking,
CDR Cecily Jones,
CDR Jeremy L Wally, PhD,
Chao Ming Tsai,
Christian D Lynch (CDL),
Christina J Sauder, PhD,
Christopher J Adams,
Craig D Zagata,
Cynthia Jim, CSO,
Dave Hafner,
David J Hafner,
David S Cho, PhD,
Debra J Bennett,
Debra L Pagano,
Dr. Gang Wang, PhD,
Eileen A Liu,
Ellen Huang,
Gene D Arcy,
Hala L Selby,
Haruhiko Murata,
Helen B Ricalde,
J David Doleski,
Jacqueline Mdiaz Albertini,
James M Mason,
James R Evans,
Jean Lhu Primmer,
Joan A Loreng,
Joan Adamo,
Joanne M Hajoway,
John D Finkbohner, PhD,
John M Mcinnis,
John M Mclnnis,
Joseph George,
Julianne C Mccullough,
Junho Pak,
Karyn M Campbell,
Kathleen B Mihalik,
Kathryn Carbone, MD,
Kelly N Kerr,
Kenneth M Gordon,
Kristen D Evans,
Laurie P Norwood,
LCDR Margaret Edi Gennaro,
Lewis K Antwi,
Linda Thai,
Lisa M Bellows,
Lisa M Feola,
Lori A Carr,
LT John M Mastalski,
Marian E Major, PhD,
Marion Michaelis,
Mark A Elengold,
Maryna C Eichelberger, PhD,
Michael Curbarg,
Michael Gurbarg,
Michael J Vardon,
Michael Merchlinsky,
Mihaly S Ligmond,
Nicholas Obiri, PhD,
Omotunde O Osunsanmi,
Pankaj H Amin,
Paul W Keller,
Paula A Trost,
Penny H Mccarver,
Prabhu P Raju,
Priscilla M Pastrana,
Qiao Y Bobo,
Ramon E Martinez,
Randa Melhem, PhD,
Rebecca K Olin,
Robert B Shibuya, MD,
Robert D Tollefsen,
Robert Jennings,
Robin Levis, PhD,
Rose Ashley,
Scott E Norris,
Sheila Dreher Lesnick,
Shuang Tang,
Sidney B Priesmeyer,
Simone E Pitts,
Stephanie Mangigian, MS/OSH, RN,
Stephen D Brown,
Susan F Laska, MS,
Susan M Jackson,
Tammy L Chavis,
Thai D Truong,
Tina S Roecklein,
Unnee Ranjan,
Vlada Matusovsky,
Wei Wang, PhD,
Xianghong Jing (Emily), PhD,
Xiao Wang,
Zhiping Ye, PhD
Steven A Rubin's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| October, 2000 | EIR | Merck Sharp & Dohme LLC - EIR, 2000-10-11 |
| October, 2000 | FDA 483 | Merck Sharp & Dohme LLC - Form 483, 2000-10-11 |
| April, 2012 | FDA 483 | Seqirus Pty Ltd - Form 483, 2012-04-24 |
| March, 2007 | FDA 483 | MEDIMMUNE U.K. LIMITED - Form 483, 2007-03-29 |
| May, 2016 | EIR | Seqirus Inc - EIR, 2016-05-17 |
| May, 2016 | FDA 483 | Seqirus Inc - Form 483, 2016-05-17 |
| May, 2006 | FDA 483 | Seqirus Vaccines Limited - Form 483, 2006-05-26 |
| February, 2013 | FDA 483 | Merck Sharp & Dohme LLC - Form 483, 2013-02-06 |
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