FDA Investigator Amanda E Lewin, PhD
Amanda E Lewin, PhD has conducted inspections on 28 sites in 7 countries as of 02 Mar 2020. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
28
Last Inspection Date:
02 Mar 2020
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
India,
Canada,
New Zealand,
Germany,
United States of America,
United Kingdom of Great Britain and Northern Ireland,
Colombia
FDA Investigators that have inspected at least one site in common with Amanda E Lewin, PhD:
Alan P Kurtzberg,
Alanna L Mussawwir Bias,
Alia Legaux,
Allen F Hall,
Amanda J White,
Andrace L Deyampert,
Anita R Michael,
Anthony E Keller, RPh,
Anthony N Onianwa,
Arindam Dasgupta, PhD,
Aurora Miha Trifanov,
Azza Talaat,
Barbara A Rusin,
Barbara D Wright,
Barbara Janine Breithaupt,
Barbara M Frazier,
Bonita S Chester,
Brenda W Uratani, PhD,
Bruce H Mccullough,
Camerson E Moore,
Cara M Minelli,
Carla J Lundi,
Charanjeet Jassal,
Charisse K Green,
Charles A Snipes, PhD,
Charles D Brown,
Courtney N Long,
Craig A Garmendia,
Cynthia White,
Daniel L Aisen,
David R Heiar,
Dawn C Olenjack,
Diane L Raccasi,
Douglas A Campbell,
Dr. Abhijit Raha, PhD,
Dr. Gopa Biswas, PhD,
Dr. Sriram Subramaniam, PhD,
Dr. Zhou Chen (nmi), MD PhD,
Dustin P Tran,
Dylan D Yao, MD, PhD,
Edward D Harris,
Edward D Vains,
Eileen A Liu,
Eric M Mueller, PharmD,
Felix Maldonado,
Gajendiran Mahadevan, PhD,
Geoffrey K Kilili,
Gulshan R Anand,
Hasan A Irier, PhD,
Hector Jcolon Torres,
Himanshu Gupta, PhD,
Humberto Z Gomez,
Hyojong Kwon, PhD,
Iram R Hassan, PhD,
Israel Santiago, OCM,
Ivis L Negron,
James A Jagon,
James R Fleckenstein,
Jane M Kreis,
Janete F Guardia,
Jeanne J Thai,
Jennifer C Adams,
Jennifer Lalama,
Joanne E King,
Joanne M Schlossin,
John A Iwen,
John A Kadavil, PhD,
John S Hartford,
Joseph L Despins, PhD,
Joy P Matthias,
Julian C Hanson,
Kara A Scheibner, PhD,
Karen M Cooper,
Katherine Szestypalow,
Kathryn A Krentz,
Kevin A Gonzalez,
Kimberly A Benson,
Kip J Hanks,
Kirtida Patel,
Li Hongpaul Yeh, PhD,
Linda R Kuchenthal,
Lori A Gioia,
Makini Cobourne Duval, PhD,
Marc R Dickens,
Marcus F Yambot,
Margaret M Annes,
Mark R Mcclain,
Matthew B Casale,
Matthew C Watson,
Matthew J Gretkierewicz,
Melkamu Getie Kebtie, PhD,
Michael F Skelly, PhD,
Michael Serrano,
Michelle M Noe Varga,
Mike M Rashti,
Minh D Phan,
Mohsen Rajabi Abhari, FDA,
Mra Mcculloughj,
Nathan R Moon,
Nicholas F Lyons,
Nicola M Fenty Stewart,
Niraj R Mehta, PhD,
Paul A Bonneau,
Paula J Bretz,
Rafael Padilla,
Rebecca T Davis,
Regina T Brown,
Richard H Penta,
Richard W Berning,
Roger F Zabinski,
Ruben C Ayala, PharmD,
Russell K Riley,
Sandra S Saniga,
Sarmistha Sanyal, PhD,
Scott B Laufenberg,
Shalonda C Clifford,
Sharon K Thoma, PharmD,
Sheri L Stephenson,
Sherri N Rohlf, MD,
Sripal R Mada, PhD,
Stanley Au,
Stephanie Mangigian, MS/OSH, RN,
Steven M Weinman,
Stuart W Russell,
Susanne M Richardson, MS RAC,
Tara K Carmody,
Tawny L Colling,
Thea C Grome,
Theressa B Smith,
Thomas W Gordon,
Tiffani D Wilson,
Traci C Kelm,
Truong Xuan Nguyen (Andy),
Uttaniti Limchumroon (Tom),
Wayne T Smith,
Wr Bowman,
Xiaohan Cai, PhD,
Xikui Chen (nmi), PhD,
Yiying E Chen,
Yiyue Zhang (nmi), PhD,
Zachary A Bogorad
Amanda E Lewin, PhD's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| March, 2017 | EIR | VEEDA CLINICAL RESEARCH LIMITED - EIR, 2017-03-24 |
| January, 2017 | FDA 483 | Charles River Laboratories, Inc - Form 483, 2017-01-13 |
| April, 2018 | EIR | Cambridge Biomedical Research Group Inc. - EIR, 2018-04-20 |
| January, 2017 | EIR | Charles River Laboratories, Inc - EIR, 2017-01-13 |
| March, 2018 | FDA 483 | BioAgilytix - Form 483, 2018-03-02 |
| July, 2017 | EIR | Charles River Laboratories Ashland, LLC - EIR, 2017-07-21 |
| March, 2020 | FDA 483 | Kyowa Kirin Pharmaceutical Research, Inc. - Form 483, 2020-03-06 |
| January, 2019 | EIR | QPS, LLC - EIR, 2019-01-16 |
| July, 2017 | FDA 483 Response | Charles River Laboratories Ashland, LLC - Form 483R, 2017-08-10 |
| July, 2017 | FDA 483 | Charles River Laboratories Ashland, LLC - Form 483, 2017-07-21 |
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