FDA Person
FDASteven E. Bowen
View detailed information about Steven E. Bowen, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 2 inspections of 2 companies, 2019.
Inspections (2)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 23, 2019 | Northern Soy, Inc. | NAI | Foodborne Biological Hazards | #1103021 |
| September 12, 2019 | SAFC Carlsbad Inc. | VAI | Human Cellular, Tissue, and Gene Therapies | #1108089 |
Documents (12)
- EIR · Brammer Bio MA, LLC · February 10, 2021
- EIR · Lonza Houston, Inc · December 10, 2020
- EIR · Abbvie Biotechnology Ltd. · January 13, 2017
- 483 · Merck Teknika LLC · January 14, 2020
- 483 · Brammer Bio MA, LLC · February 10, 2021
- 483 · Brammer Bio MA, LLC · February 10, 2021
- 483 · Lonza Houston, Inc · December 10, 2020
- 483 · Novartis Gene Therapies, Inc. · June 16, 2021
- 483 · Haematologic Technologies, LLC dba Prolytix · July 30, 2021
- 483 · Toyobo Co. Ltd. · July 30, 2019
- 483 · Spark Therapeutics, Inc. · March 4, 2022
- 483 · SAFC Carlsbad Inc. · September 12, 2019
Frequently inspected with (3)
Person Information
Name
Steven E. Bowen
Title
Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics
Role
Regulatory Personnel
ID: 0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c
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