Overview
- 9 inspections across 8 sites are on record.
- 0 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-10-28.
At a glance
Inspections
9
Sites
8
Observations
0
Career since
Mar 2016
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Lonza AG | 28 Oct 2025 | Human Drugs | On file |
| Shanghai Henlius Biologics Co., Ltd. | 24 Jan 2025 | Human Drugs | On file |
| Novo Nordisk A/S | 25 Mar 2024 | Human Drugs | On file |
| CELLTRION Inc | 27 Feb 2024 | Human Drugs | On file |
| Biocon Biologics Limited | 26 Aug 2022 | Human Drugs | On file |
Sites inspected
Lonza AGVisp, Switzerland1 insp.
Shanghai Henlius Biologics Co., Ltd.Shanghai, China1 insp.
Novo Nordisk A/SKalundborg, Denmark1 insp.
CELLTRION IncYeonsu District, Korea (the Republic of)1 insp.
Biocon Biologics LimitedBengaluru, India1 insp.
Co-investigators
Investigators who share inspections with this person.
Zhong Li4 shared
Arsen Karapetyan2 shared
Alexander R Sohr1 shared
Gunther H Boekhoudt1 shared
Lei Zhang1 shared
Reyes Candau-Chacon1 shared
Hao Kiet D Phan1 shared
Hyung-Yul Lee1 shared
Lindsey J Brown1 shared
Saleem A Akhtar1 shared
Full investigator report
Get the verbatim findings behind Ralph M Bernstein's inspection record
Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.
- New inspections and Form 483s, mapped to the CFR citation
- Warning letter outcomes, and the citation patterns they repeat
- Their co-investigators, so no surprises about who shows up on site