FDA Person
FDAPrabhu P. Raju
View detailed information about Prabhu P. Raju, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 33 inspections of 33 companies, 2016–2023.
Inspections (33)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| May 4, 2023 | Novo Nordisk A/S | VAI | Blood and Blood Products | #1209127 |
| April 25, 2023 | Sanofi Winthrop Industrie | VAI | Vaccines and Allergenic Products | #1206033 |
| March 9, 2023 | Unigen Inc. | VAI | Vaccines and Allergenic Products | #1202548 |
| February 28, 2023 | Samsung Biologics Co., Ltd. | VAI | Blood and Blood Products | #1201856 |
| September 20, 2019 | Merck Sharp & Dohme LLC | VAI | Vaccines and Allergenic Products | #1103540 |
| August 2, 2019 | Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell Laboratory | Not classified | #1110495 | |
| May 31, 2019 | Baxalta Belgium Manufacturing SA | VAI | Blood and Blood Products | #1093550 |
| May 17, 2019 | Vetter Pharma Fertigung GmbH & Co. KG | Not classified | #1095644 | |
| April 18, 2019 | Bloodworks | VAI | Human Cellular, Tissue, and Gene Therapies | #1087821 |
| February 26, 2019 | Oxford Biomedica (UK) Limited | NAI | Human Cellular, Tissue, and Gene Therapies | #1088830 |
| February 20, 2019 | Oxford Biomedica (UK) Limited | VAI | Human Cellular, Tissue, and Gene Therapies | #1082991 |
| December 4, 2018 | National Genetics Institute | VAI | Blood and Blood Products | #1074132 |
| October 18, 2018 | CSL Behring L.L.C. | VAI | Blood and Blood Products | #1072948 |
| September 28, 2018 | Octapharma AB | VAI | Blood and Blood Products | #1070173 |
| September 17, 2018 | Alk-abello A/s | VAI | Vaccines and Allergenic Products | #1068935 |
| July 17, 2018 | Patheon Manufacturing Services LLC | VAI | Vaccines and Allergenic Products | #1060475 |
| May 17, 2018 | CSL Behring GmbH | Not classified | #1052244 | |
| April 18, 2018 | Ortho-Clinical Diagnostics, Inc. | VAI | Blood and Blood Products | #1054495 |
| March 2, 2018 | MD Anderson Cord Blood Bank | Not classified | #1048361 | |
| February 2, 2018 | Takeda Manufacturing Austria AG | Not classified | #1043241 |
Documents (45)
- 483 · Juno Therapeutics, Inc. · October 16, 2020
- EIR · National Genetics Institute · December 4, 2018
- 483 RESPONSE · Juno Therapeutics, Inc. · October 16, 2020
- EIR · Juno Therapeutics, Inc. · October 16, 2020
- EIR · CSL Behring L.L.C. · October 18, 2018
- EIR · CMC Biologics · April 20, 2017
- EIR · Cangene Corporation · May 16, 2017
- 483 · CSL Behring GmbH · March 4, 2022
- 483 · Unigen Inc.
- 483 · ADMA Biologics, Inc · August 3, 2021
- EIR · Jubilant HollisterStier LLC · November 16, 2016
- 483 · Aventis Pasteur Ltd. · October 1, 2000
- 483 · Biotest Pharmaceuticals Inc. · November 8, 2007
- 483 · Patheon Manufacturing Services LLC · July 11, 2018
- EIR · Patheon Manufacturing Services LLC · July 17, 2018
- 483 · Takeda Manufacturing Singapore Pte. Ltd. · November 10, 2022
- EIR · CSL Behring GmbH · March 4, 2022
- 483 · Novo Nordisk A/S · May 4, 2023
- 483 · AGC Biologics, Inc. · July 12, 2021
- 483 · Merck Sharp & Dohme LLC · September 9, 2019
- 483 · CSL Behring AG · February 10, 2020
- 483 · Oxford Biomedica (UK) Limited · February 11, 2019
- 483 · Sanofi Winthrop Industrie · April 17, 2023
- EIR · Seqirus Inc · May 17, 2016
- 483 · CSL Behring L.L.C. · September 24, 2021
- EIR · Emergent BioSolutions Canada Inc. · May 16, 2017
- 483 · Vetter Pharma Fertigung GmbH & Co. KG · May 13, 2019
- 483 · Baxalta Belgium Manufacturing SA · May 20, 2019
- 483 · Seqirus Inc · May 10, 2016
- 483 · Millipore (U.K.) Ltd. · February 27, 2020
- 483 · Samsung Biologics Co., Ltd. · February 20, 2023
- 483 · Bio-Rad Laboratories, Inc. · December 13, 2021
- EIR · AGC Biologics, Inc. · July 23, 2021
- 483 · MassBiologics · July 13, 2010
- 483 · Pharmacia & Upjohn Company LLC · May 11, 2021
- 483 · Emergent BioSolutions Canada Inc. · May 16, 2017
- 483 · Takeda Manufacturing Austria AG · June 13, 2022
- 483 · Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell Laboratory · August 2, 2019
- 483 · GlaxoSmithKline Biologicals · November 8, 2022
- 483 · Sanofi Winthrop Industrie · September 18, 2017
- 483 · CSL Behring GmbH · May 17, 2018
- EIR · ADMA Biologics, Inc · August 12, 2021
- 483 · Bayer HealthCare, LLC · November 13, 2019
- EIR · Merck Sharp & Dohme LLC · September 20, 2019
- 483 · Unigen Inc. · March 9, 2023
Frequently inspected with (10)
Person Information
Name
Prabhu P. Raju
Title
Program Expert for Advanced Manufacturing
Role
Regulatory Personnel
ID: 2c0aaede-fe16-4431-bc21-614d7f18cb32
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