FDA Investigator: Michael Shanks
- Michael Shanks first started conducting FDA inspections in 2015, with the last inspection in 2024. Over that time, Michael Shanks has conducted 63 inspections at 49 companies across 59 sites.
Documents
FDA 483 Genentech, South San Francisco | February 2023
Available - $199
Michael Shanks
Human Drugs Form 483
FDA 483 Ajinomoto Althea, San Diego | January 2023
Available - $199
Michael Shanks
Human Drugs Form 483
FDA 483 Intas Pharmaceuticals, Ahmedabad | August 2022
Available - $199
Michael Shanks
Human Drug Form 483
FDA 483 Pyramid Laboratories, Costa Mesa | February 2021
Available - $199
Michael Shanks
Human Drug Form 483
FDA 483 Aspen SVP Pty, Port Elizabeth | December 2018
Available - $199
Michael Shanks
Human Drug Form 483
FDA 483 Biogen Idec (Denmark) Manufacturing ApS | Oct 2017
Available - $199
Michael Shanks
Human Drug Form 483
FDA 483 Human Genome Sciences, Rockville | July 2015
Available - $199
Michael Shanks
Human Drug Form 483
FDA 483 MSD Ireland (Carlow), Carlow | 2024
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 BioConnection B.V., Oss | 2024
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 BSP Pharmaceuticals SpA, Latina | 2024
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Patheon Biologics LLC, Saint Louis | 2023
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Patheon Biologics Australia Pty Ltd, Woolloongabba | 2023
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Bio-Thera Solutions, Guangzhou | 2023
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Shanghai Henlius Biologics Co., Ltd, Shanghai | 2023
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Roche Diagnostics GmbH, Penzberg | 2023
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Tanvex BioPharma USA, Inc, San Diego | 2023
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Eli Lilly & Company, Indianapolis | 2022
Out-of-stock
Michael Shanks
Human Drugs Form 483
FDA 483 Biocon Biologics Limited, Bengaluru | 2022
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Hanmi Pharma Co., Ltd, Pyeongtaek | 2022
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Patheon Biologics LLC, Saint Louis | 2022
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Polpharma Biologics S.A, Gdansk | 2022
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Wasserburger Arzneimittelwerk GmbH, Wasserburg a. Inn | 2022
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 GlaxoSmithKline Manufacturing S.p.A., Torrile | 2021
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Wacker Biotech GmbH, Jena | 2021
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Patheon Italia S.p.A., Monza | 2021
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Catalent Indiana, LLC, Bloomington | 2020
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Ajinomoto Althea, Inc., San Diego | 2019
Out-of-stock
Michael Shanks
Human Drug Form 483
FDA 483 Vetter Pharma Fertigung GmbH & Co. KG, Ravensburg | 2019
Out-of-stock
Michael Shanks
Human Drug Form 483
Co-Investigators (44)
- Scott C. Lute, FDA Investigator
- Bingchen Du, FDA Investigator
- Jill J. Tillman, FDA Investigator
- Hamet M. Toure, FDA Investigator
- Yun Wu, FDA Investigator
- Nayan J. Patel, FDA Investigator
- Yi Wang, FDA Investigator
- Bryan A. Galvez, FDA Investigator
- Christopher R. Czajka, FDA Investigator
- Joseph A. Piechocki, FDA Investigator
- Arsen Karapetyan, FDA Investigator
- Zhong Li, FDA Investigator
- Ralph M. Bernstein, FDA Investigator
- Matthew B. Casale, FDA Investigator
- Jacek Cieslak, FDA Investigator
- Michael A. Charles, FDA Investigator
- Unnee Ranjan, FDA Investigator
- Lindsey J. Brown, FDA Investigator
- Santiago Gallardo Johnson, FDA Investigator
- Virginia A. Carroll, FDA Investigator
- Gallardo Johnson, Santiago, FDA Investigator
- Ashley N. Queen, FDA Investigator
- Diane L. Raccasi, FDA Investigator
- Cheryl A. Clausen, FDA Investigator
- David A. Oluwo, FDA Investigator
- Alice S. Tsao, FDA Investigator
- Simone E. Pitts, FDA Investigator
- James M. Simpson, FDA Investigator
- Alison N. Stieg, FDA Investigator
- Ziyang Su, FDA Investigator
- Marion Michaelis, FDA Investigator
- Laura Fontan, FDA Investigator
- Steven Fong, FDA Investigator
- Jessica Hankins, FDA Investigator
- Justin A. Boyd, FDA Investigator
- Reyes Candau-Chacon, FDA Investigator
- Lakshmi Ran Narasimhan, FDA Investigator
- Scott R. Nichols, FDA Investigator
- Nealie C. Newberger, FDA Investigator
- Bo Chi, FDA Investigator
- Jose F. Velez, FDA Investigator
- Thuy T. Nguyen, FDA Investigator
- Wayne E. Seifert, FDA Investigator
- Zhihao Pete Qiu, FDA Investigator