FDA Person
Center for Drug Evaluation and ResearchMichael R. Shanks
View detailed information about Michael R. Shanks, including compliance records, violations, and related data.
Person Profile
FDA investigator, Center for Drug Evaluation and Research. Took part in 1 inspection of 1 company, 2024.
Inspections (1)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| February 29, 2024 | BSP Pharmaceuticals SpA | Not classified | #1232171 |
Documents (52)
- EIR · Hanmi Pharma Co., Ltd · June 2, 2021
- 483 · Catalent Indiana, LLC · September 2, 2020
- 483 · Biocon Biologics Limited · April 7, 2017
- 483 · Biocon Biologics Limited · February 15, 2019
- EIR · Pharmaceutics International, Inc. · November 9, 2018
- 483 · Alvotech HF · January 19, 2024
- EIR · Ajinomoto Althea, Inc. · December 20, 2019
- 483 · Hanmi Pharma Co., Ltd · July 5, 2022
- 483 · Pyramid Laboratories, Inc.
- 483 · MediWound Ltd · November 15, 2022
- EIR · Eli Lilly & Company · October 21, 2022
- 483 · Pharmaceutics International Inc · November 9, 2018
- 483 · Patheon Biologics Australia Pty Ltd · October 17, 2023
- 483 · Polpharma Biologics S.A
- 483 · Patheon Biologics LLC · May 2, 2022
- 483 · AGC Biologics, Inc. · March 27, 2024
- 483 · Roche Diagnostics GmbH
- 483 · MSD Ireland (Carlow)
- 483 · BioConnection B.V. · March 4, 2024
- EIR · Pyramid Laboratories, Inc. · February 3, 2021
- 483 · GlaxoSmithKline Manufacturing S.p.A.
- 483 · Catalent Indiana, LLC
- 483 · Bio-Thera Solutions, Ltd. · August 18, 2023
- 483 · Lonza AG (Standort Sterilprodktion Stein)
- 483 · Tanvex BioPharma USA, Inc · January 24, 2023
- 483 · AGC Biologics A/S
- 483 · GlaxoSmithKline Manufacturing S.p.A. · November 12, 2021
- 483 · Genentech, Inc. · January 31, 2023
- 483 · ENDO USA, Inc.
- 483 · Eli Lilly & Company · October 17, 2022
- 483 · Astellas Pharma Inc. · October 7, 2019
- 483 · Ajinomoto Althea, Inc. · January 16, 2023
- 483 · Intas Pharmaceuticals Ltd. · August 9, 2022
- 483 · Sandoz GmbH
- 483 · Patheon Biologics LLC · November 10, 2023
- 483 · Samsung Biologics Co., Ltd.
- 483 · Ajinomoto Althea, Inc.
- 483 · Biocon Biologics Limited
- 483 · Shanghai Henlius Biologics Co., Ltd. · August 1, 2023
- 483 · Patheon Italia S.p.A.
- 483 · Aspen SA Sterile Operations (Pty) Ltd. · December 4, 2018
- EIR · Samsung Biologics Co., Ltd. · May 11, 2018
- 483 · Wasserburger Arzneimittelwerk GmbH
- 483 · BSP Pharmaceuticals SpA · February 29, 2024
- 483 · Eli Lilly & Company · October 21, 2022
- 483 · Polpharma Biologics S.A · March 22, 2022
- 483 · MSD Ireland (Carlow) · May 28, 2024
- 483 · Roche Diagnostics GmbH · March 10, 2023
- 483 · Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
- 483 · KBI Biopharma, Inc. · June 18, 2024
- 483 · Wacker Biotech GmbH
- 483 · Biocon Biologics Limited · August 26, 2022
Related Office
Person Information
Name
Michael R. Shanks
Title
Investigator
Role
Regulatory Personnel
ID: dd24952b-4309-451e-afe8-f68892cd7bac
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