Overview
- 6 inspections across 6 sites are on record.
- 43 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2024-08-29.
At a glance
Inspections
6
Sites
6
Observations
43
Career since
Sep 2017
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Novo Nordisk Pharmaceutical Industries LP | 29 Aug 2024 | Human Drugs | View 483 → |
| ARx, LLC | 29 Mar 2019 | Human Drugs | View 483 → |
| Teva Womens Health, LLC | 8 Feb 2019 | Human Drugs | View 483 → |
| Laboratorios Leon Farma SAU | 25 May 2018 | Medical Devices & Rad Health | View 483 → |
| Sever Pharma Solutions AB | 15 Dec 2017 | Human Drugs | On file |
Sites inspected
Novo Nordisk Pharmaceutical Industries LPDurham, United States1 insp.
ARx, LLCGlen Rock, United States1 insp.
Teva Womens Health, LLCCincinnati, United States1 insp.
Laboratorios Leon Farma SAUVillaquilambre, Spain1 insp.
Sever Pharma Solutions ABMalmo, Sweden1 insp.
Co-investigators
Investigators who share inspections with this person.
Simone E Pitts2 shared
Sarah C Zimmermann1 shared
Chunsheng Cai1 shared
Marian E Ramirez1 shared
Craig D Zagata1 shared
Alice S Tsao1 shared
Lauren N Howard1 shared
Michael L Casner1 shared
Seema S Singh1 shared
Youmin Wang1 shared
Full investigator report
Get the verbatim findings behind James Norman's 43 observations
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