Overview
- 13 inspections across 13 sites are on record.
- 1 Form 483 observation is attributed to this investigator.
- Most recent recorded activity is 2015-11-04.
At a glance
Inspections
13
Sites
13
Observations
1
Career since
Jan 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Telesta Therapeutics Inc. | 4 Nov 2015 | Human Drugs | On file |
| N.V. Organon | 8 Apr 2014 | Biologics | On file |
| Broekman Institute | 31 Mar 2014 | Biologics | |
| Tjoapack Netherlands BV | 28 Mar 2014 | Biologics | On file |
| Bora Pharmaceuticals Injectables Inc | 8 May 2013 | Biologics | On file |
Sites inspected
Telesta Therapeutics Inc.Pointe-Claire, Canada1 insp.
N.V. OrganonOss, Netherlands1 insp.
Broekman InstituteSomeren, Netherlands1 insp.
Tjoapack Netherlands BVEtten-Leur, Netherlands1 insp.
Bora Pharmaceuticals Injectables IncBaltimore, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Richard H Coats3 shared
Donald B Ertel2 shared
Kevin P Foley1 shared
Michael J Vardon1 shared
Quyen T Tran1 shared
Nancy T Waites1 shared
Qiao Y Bobo1 shared
Lori P Peters1 shared
Joseph George1 shared
Sarah B Tanksley1 shared
Full investigator report
Get the verbatim findings behind Nicole K Trudel's 1 observation
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