Overview
- 17 inspections across 16 sites are on record.
- 0 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2019-08-02.
At a glance
Inspections
17
Sites
16
Observations
0
Career since
May 2009
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Carolinas Cord Blood Bank | 2 Aug 2019 | Biologics | On file |
| GlaxoSmithKline Biologicals | 13 Nov 2018 | Biologics | On file |
| Novartis Pharmaceuticals Corporation | 7 Apr 2017 | Biologics | On file |
| Baxalta US Incorporated | 24 Jun 2016 | Biologics | On file |
| Baxalta Belgium Manufacturing SA | 23 Oct 2014 | Biologics | On file |
Sites inspected
Carolinas Cord Blood BankDurham, United States1 insp.
GlaxoSmithKline BiologicalsSaint-Amand-Les-Eaux, France1 insp.
Novartis Pharmaceuticals CorporationMorris Plains, United States1 insp.
Baxalta US IncorporatedLos Angeles, United States1 insp.
Baxalta Belgium Manufacturing SALessines, Belgium1 insp.
Co-investigators
Investigators who share inspections with this person.
Destry M Sillivan3 shared
Lily Y Koo2 shared
Jie He2 shared
Anthony F Lorenzo2 shared
Sukhanya Jayachandra1 shared
Thomas P Finn1 shared
Ekaterina Allen1 shared
Prabhu P Raju1 shared
Ashley J Burns1 shared
Joan Johnson1 shared
Full investigator report
Get the verbatim findings behind Randa Melhem'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