FDA Person
FDADebra M. Emerson
View detailed information about Debra M. Emerson, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 22 inspections of 22 companies, 2016–2019.
Inspections (22)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 27, 2019 | Biovex, Inc. | Not classified | #1109494 | |
| September 12, 2019 | GenTrac, Inc. | VAI | Blood and Blood Products | #1102063 |
| June 24, 2019 | GlaxoSmithKline Biologicals SA | Not classified | #1099401 | |
| June 24, 2019 | GlaxoSmithKline Biologicals SA | Not classified | #1099397 | |
| May 17, 2019 | Charles River Laboratories, Inc. DBA Charles River, Endosafe | VAI | Blood and Blood Products | #1091172 |
| April 16, 2019 | Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. | VAI | Blood and Blood Products | #1090370 |
| April 5, 2019 | SmartPractice Denmark ApS | VAI | Vaccines and Allergenic Products | #1090369 |
| February 16, 2019 | Cangene BioPharma, LLC | VAI | Vaccines and Allergenic Products | #1084658 |
| December 18, 2018 | Sanofi Winthrop Industrie | Not classified | #1076287 | |
| December 10, 2018 | Sanofi Winthrop Industrie | Not classified | #1080126 | |
| November 8, 2018 | Associates of Cape Cod, Inc. | VAI | Blood and Blood Products | #1081549 |
| June 13, 2018 | Bora Pharmaceuticals Injectables Inc | VAI | Blood and Blood Products | #1056814 |
| May 24, 2018 | AbbVie Bioresearch Center | VAI | Blood and Blood Products | #1056813 |
| April 18, 2018 | Ortho-Clinical Diagnostics, Inc. | VAI | Blood and Blood Products | #1054495 |
| February 23, 2018 | OKC Allergy Supplies, Inc. | VAI | Drug Quality Assurance | #1042419 |
| December 21, 2017 | Emergent Biosolutions LLC | VAI | Vaccines and Allergenic Products | #1041003 |
| August 24, 2017 | Novartis Pharma Stein AG | Not classified | #1025563 | |
| August 15, 2017 | Baxalta Manufacturing Sarl | Not classified | #1025564 | |
| July 19, 2017 | CSL Behring L.L.C. | VAI | Blood and Blood Products | #1019044 |
| April 28, 2017 | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | VAI | Vaccines and Allergenic Products | #1020234 |
Documents (47)
- 483 · Alaunus Pharmaceutical, LLC · November 16, 2012
- 483 · Resilience US, Inc. · November 13, 2009
- 483 · Jubilant HollisterStier LLC · December 2, 2014
- 483 · New England Compounding Pharmacy Inc., d/b/a New England Compounding Center · October 26, 2012
- EIR · Catalent Maryland Inc · November 17, 2021
- 483 · Village Fertility Pharmacy, Inc. · March 13, 2013
- 483 · Central Admixture Pharmacy Services, Inc. · January 29, 2013
- 483 · Emergent Manufacturing Operations Baltimore LLC. · April 20, 2021
- EIR · Rentschler Biopharma Inc. · December 13, 2019
- 483 RESPONSE · Emergent Manufacturing Operations Baltimore LLC. · April 20, 2021
- EIR · AbbVie Bioresearch Center · May 24, 2018
- 483 · CSL Behring GmbH · March 4, 2022
- 483 · GenTrac, Inc. · September 12, 2019
- EIR · Covis Pharma GmBH · August 3, 2011
- EIR · Associates of Cape Cod, Inc. · November 8, 2018
- EIR · CSL Behring GmbH · March 4, 2022
- 483 · Emergent BioSolutions Canada Inc. · May 10, 2022
- EIR · bluebird bio, Inc. · March 9, 2021
- 483 · Emergent BioSolutions Canada Inc. · July 18, 2014
- 483 · Cangene bioPharma, LLC., dba Emergent BioSolutions
- 483 · bluebird bio, Inc.
- 483 · CSL Behring L.L.C. · September 24, 2021
- 483 · Charles River Laboratories, Inc. DBA Charles River, Endosafe · January 13, 2016
- 483 · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · April 28, 2017
- 483 · Biovex, Inc. · September 27, 2019
- 483 · Rentschler Biopharma Inc.
- 483 · Charles River Laboratories, Inc. DBA Charles River, Endosafe
- 483 · Resilience Biotechnologies, Inc. · February 7, 2020
- 483 · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · July 23, 2021
- 483 · GlaxoSmithKline Biologicals SA · June 24, 2019
- 483 · ID Biomedical Corporation of Quebec · May 20, 2022
- 483 · Emergent BioSolutions Canada Inc. · May 10, 2022
- 483 · LFB USA, Inc.
- EIR · Cangene BioPharma, LLC · June 13, 2018
- EIR · Cangene BioPharma, LLC · February 16, 2019
- 483 · Lonza Biologics, Inc. · May 3, 2011
- 483 · Bavarian Nordic Berna GmbH
- 483 · Resilience US, Inc. · October 10, 2008
- 483 · Covis Pharma GmBH · August 3, 2011
- 483 · Bora Pharmaceuticals Injectables Inc
- 483 · Associates of Cape Cod, Inc. · November 8, 2018
- 483 · Rentschler Biopharma Inc.
- 483 · MassBiologics · November 19, 2019
- 483 · Emergent Biosolutions LLC · December 21, 2017
- 483 · Lonza Biologics, Inc. · October 22, 2021
- 483 · Catalent Maryland Inc · November 17, 2021
- 483 · Hisun Pharmaceutical (Nantong) Co., Ltd. · July 12, 2024
Frequently inspected with (10)
Susan M. Jackson
investigator
5 shared
Jie He
2 shared
Leslie D. Wagner
2 shared
Shuang Tang
Research Biologist
2 shared
Arie Menachem
1 shared
Cynthia Jim
1 shared
Dino A. Feigelstock
1 shared
Jacqueline M. Diaz Albertini
investigator
1 shared
James L. Kenney
1 shared
Jonathan G. Matrisciano
Program Division Director/District Director
1 shared
Person Information
Name
Debra M. Emerson
Title
Strategic Expert at NovoNordisk; Retired from FDA
Role
Regulatory Personnel
ID: 58bd7fac-28eb-4369-b149-13a24cc00cf7
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