FDA Person
FDARalph M. Bernstein
View detailed information about Ralph M. Bernstein, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 5 inspections of 5 companies, 2018–2025.
Inspections (5)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| October 28, 2025 | Lonza AG | Not classified | #1303682 | |
| January 24, 2025 | Shanghai Henlius Biologics Co., Ltd. | Not classified | #1287688 | |
| March 25, 2024 | Novo Nordisk A/S | Not classified | #1269488 | |
| February 27, 2024 | Celltrion Inc. | VAI | Drug Quality Assurance | #1233221 |
| September 12, 2018 | KBI Biopharma, Inc. | Not classified | #1066025 |
Documents (14)
- EIR · Rentschler Biopharma SE · February 15, 2022
- EIR · Novo Nordisk A/S · March 25, 2024
- 483 · MSD Ireland (Carlow) · May 28, 2024
- 483 · Samsung Biologics Co., Ltd. · March 14, 2018
- 483 · Lonza AG · March 29, 2019
- 483 · MSD Ireland (Carlow)
- 483 · Daiichi Sankyo Chemical Pharma Co., Ltd. · November 8, 2019
- 483 · Celltrion Inc. · June 3, 2022
- 483 · Lonza AG · October 28, 2025
- 483 · Novo Nordisk A/S · March 25, 2024
- 483 · Rentschler Biopharma SE · February 15, 2022
- 483 · Shanghai Henlius Biologics Co., Ltd. · January 24, 2025
- 483 · Celltrion Inc. · February 27, 2024
- 483 · Biocon Biologics Limited · August 26, 2022
Frequently inspected with (10)
Person Information
Name
Ralph M. Bernstein
ID: 72173dfb-24ae-42a1-af9e-1dc7da02ed87
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