FDA Investigator James L Dunnie, Jr
James L Dunnie, Jr has conducted inspections on 39 sites in 13 countries as of 20 Jun 2016. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
39
Last Inspection Date:
20 Jun 2016
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Canada,
Germany,
Italy,
Sweden,
India,
Spain,
Switzerland,
United Kingdom of Great Britain and Northern Ireland,
Denmark,
France,
Malta,
Romania,
United States of America
FDA Investigators that have inspected at least one site in common with James L Dunnie, Jr:
Ademola O Daramola,
Anastasia M Shields,
Andrea A Branche,
Anita Narula, PhD,
Ann L Demarco,
Ann Marie Montemurro,
Ann Marie Schofield,
Ariel Cruz Figueroa,
Arsen Karapetyan,
Arthur S Williams, Jr,
Ashley J Burns,
Azza Talaat,
Barbara Janine Breithaupt,
Barbara M Frazier,
Bo Chi, PhD,
Brian D Nicholson,
Bruce H Mccullough,
Carl A Huffman, III,
Carla J Lundi,
Carmen Y Fisher,
Caryn M Mcnab,
Cassandra L Abellard,
Charisse K Green,
Charles L Zhou,
Charles M Edwards,
Charles R Cote, RIC,
Chikako Torigoe, PhD,
Chris A Sack,
Christian D Lynch (CDL),
Christina Capacci Daniel, PhD,
Christopher T Middendorf,
Craig A Garmendia,
Cynthia Jim, CSO,
Daniel J Grabicki,
Daniel J Lahar,
Darren S Brown,
David J Gomes,
David J Hafner,
David M Beltran,
Debra I Love,
Dell S Moller,
Dennis Cantellops Paite,
Doan T Nguyen, PharmD,
Don H Bark, PhD,
Donald L Lech,
Dongping Dai, PhD,
Douglas A Campbell,
Dr. Barbara D Paul, PhD,
Dr. Carmelo Rosa,
Dr. Robert C Horan, MD,
Dr. Zhihao Qiu (Peter), PhD,
Edmund F Mrak, Jr,
Eliezar Ramos,
Emest F Bizjak,
Emilie E Kahn,
Erika V Butler,
Francis A Guidry,
Frank Wackes,
Frederick F Razzaghi,
George J Flynn,
George Pyramides,
Gerald B Seaborn, Jr,
Geraldine D Sanders,
German Rivera,
Ginger M Sykes,
Gloria E Parra,
Grace E Mcnally,
Guerlain Ulysse,
Gwyn G Dickinson,
Hamet M Toure, PharmD MPH,
Helen B Ricalde,
Holly Brevig,
Iram R Hassan, PhD,
Ivis L Negron,
Jacob G Lutz,
Jacqueline Mdiaz Albertini,
James C Maclaughlin,
James I Giefer,
James P Mcevoy,
Jeffrey A Sommers,
Jennifer Lalama,
Jennifer M Gogley,
Joan A Loreng,
Joanne E King,
Joey V Quitania,
John P Mistler,
Jose Acruz Gonzalez,
José E Meléndez,
Jose R Hernandez,
Junho Pak,
Justin A Boyd,
Justine Tomasso,
Karen E D'orazio,
Karen Takahashi,
Katherine Szestypalow,
Kathy E Noe,
Kellia N Hicks,
Kelvin Cheung,
Kenneth H Williams,
Kenneth Nieves,
Kevin D Kallander,
Kham Phommachanh,
Kimberley A Hoefen,
Kimberly Lewandowski Walker,
Kip J Hanks,
Ko U Min,
Kristen D Evans,
Kumar G Janoria,
Larry K Austin,
Latorie S Jones,
Laura S Huffman,
Lawrence Harmon, Jr,
LCDR Chad N Thompson,
LCDR Debra Emerson,
Liatte Kreuger, PharmD,
Linda Thai,
Lisa Hornback,
Lisa M Bellows,
Lucas B Leake,
Luis A Dasta,
Luis Mburgos Medero,
Lydia I Rosas Marty,
Marcus F Yambot,
Marie A Fadden,
Marie F Morin,
Mariza M Jafary,
Maryam Tabatabaie,
Massoud Motamed,
Matthew D Schnittker,
Matthew R Dionne,
Maya M Davis,
Meisha R Sampson,
Melissa D Ray,
Melissa J Garcia,
Meyer J Slobotsky,
Michael A Charles,
Michael E Maselli,
Michael R Goga,
Michael Shanks, MS,
Michele Gottshall,
Michele L Obert,
Michelle Yclark Stuart,
Miguel A Martinez Perez,
Mihaly S Ligmond,
Mikhail V Ovanesov, PhD,
Minh D Phan,
Mizanne E Lewis,
Mra B Kamberem,
Mra Davism,
Mra Greenc,
Mra M Barbosar,
Mra Mcculloughj,
Muralidhara B Gavini, PhD,
Nadeem I Chaudhry,
Nancy G Schmidt,
Neal L Adams,
Nebil A Oumer,
Nicholas A Violand,
Nicholas L Paulin,
Niketa Patel,
Omotunde O Osunsanmi,
Pankaj H Amin,
Paraluman S Leonin,
Parul M Patel,
Patricia F Hughes, PhD,
Patrick C Klotzbuecher,
Patrick L Wisor,
Patsy J Domingo,
Paul A Bonneau,
Paul E Stein,
Paul L Bellamy,
Paul L Figarole, Jr,
Paula A Trost,
Prabhu P Raju,
Rafael E Arroyo,
Rafael Nevarez Nieves,
Rafael Padilla,
Ralph H Vocque,
Ralph Jerndal,
Ramon E Martinez,
Raymond T Oji,
Reba A Gates,
Rebecca E Dombrowski,
Regina T Brown,
Reyes Candau Chacon, PhD,
Richard E Needham,
Richard K Vogel,
Richard L Friedman,
Robert C Coleman,
Robert C Steyert,
Robert D Tollefsen,
Robert J Doyle,
Robert J Martin,
Rodney D Combs,
Roger F Zabinski,
Rosanna M Goodrich,
Rose Ashley,
Roy R Rinc,
Russell J Glapion,
Russell K Riley,
Ruth Moore, PhD,
Saied A Asbagh,
Samantha J Bradley,
Samina S Khan,
Samuel K Gibbons, Jr,
Sangeeta M Khurana, PhD,
Santiago Gallardo Johnson,
Santos E Camara,
Satheesh Thomas,
Scott T Ballard,
Sean R Marcsisin,
Seneca D Toms,
Sergey S Akimov,
Sharon K Thoma, PharmD,
Shirley J Berryman,
Sidney B Priesmeyer,
Simone E Pitts,
Sixto M Mercado Rios,
Sneha S Patel,
Stephanie L Shapley,
Stephen C Smith,
Stephen D Brown,
Stephen D Eich,
Steven C Madzo,
Steven Frisbee,
Steven M Weinman,
Susan F Laska, MS,
Susan M Jackson,
Susan P Bruederle,
Susan T Hadman,
Susanne M Richardson, MS RAC,
Suzanne M Healy,
Suzanne M Muchene,
Tawny L Colling,
Temar Q Williams,
Theressa B Smith,
Thomas J Arista,
Thuy T Nguyen, LCDR,
Tina M Pawlowski,
Tonnie L Carter,
Torrance J Slayton,
Tracy K Li,
Truong Xuan Nguyen (Andy),
Unnee Ranjan,
Vilmary Negron Rodriguez,
Virginia Carroll, PhD,
Vlada Matusovsky,
Wayne E Seifert,
Wendy G Tan, PhD,
William A Warnick,
Xianghong Jing (Emily), PhD,
Xiaohui Shen,
Xiaokuang Lai, PhD,
Xiaoping Guan,
Yasamin Ameri,
Yehualashet A Gessesse,
Yumi J Hiramine,
Zachary A Bogorad,
Zhong Li, PhD,
Zonglin Hu
James L Dunnie, Jr's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| September, 2009 | FDA 483 | Arrow Pharm Limited - Form 483, 2009-09-17 |
| April, 2015 | FDA 483 | Torrent Pharmaceuticals Limited - Form 483, 2015-04-10 |
| October, 2001 | EIR | Takeda GmbH - EIR, 2001-10-17 |
| September, 2005 | EIR | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) - EIR, 2005-09-22 |
| November, 2000 | FDA 483 | F. Hoffmann-La Roche AG - Form 483, 2000-11-10 |
| October, 2001 | FDA 483 | Takeda GmbH - Form 483, 2001-10-17 |
| November, 2006 | EIR | Farmhispania S.A. - EIR, 2006-11-09 |
| November, 2006 | FDA 483 | Farmhispania S.A. - Form 483, 2006-11-09 |
| October, 2001 | FDA 483 Response | Takeda GmbH - Form 483R, 2001-12-14 |
| November, 2015 | FDA 483 | AstraZeneca Dunkerque Production - Form 483, 2015-11-20 |
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