Overview
- 4 inspections across 4 sites are on record.
- 0 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-05-30.
At a glance
Inspections
4
Sites
4
Observations
0
Career since
Nov 2023
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Andelyn Biosciences, Inc. | 30 May 2025 | Biologics | On file |
| ULTRAGENYX | 30 Apr 2025 | Biologics | On file |
| ULTRAGENYX | 25 Apr 2025 | Biologics | On file |
| AGC Biologics SPA | 20 Nov 2023 | Biologics | On file |
Sites inspected
Andelyn Biosciences, Inc.Columbus, United States1 insp.
ULTRAGENYXWoburn, United States1 insp.
ULTRAGENYXBedford, United States1 insp.
AGC Biologics SPABresso, Italy1 insp.
Co-investigators
Investigators who share inspections with this person.
Timothy Kamaldinov2 shared
Kula N Jha2 shared
Massoud Motamed2 shared
Susan S Butler1 shared
Holly Brevig1 shared
Christelle Mbondji Wonje1 shared
Viviana R Ramirez1 shared
Tiffany M Lucas1 shared
Erin C Hill1 shared
Jared D Greenleaf1 shared
Full investigator report
Get the verbatim findings behind Jacob L Bitterman'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