Company
United StatesSomerset Medical Center IRB, Somerville, NJ – FDA Inspections
Inspection records and compliance data for Somerset Medical Center IRB in Somerville, New Jersey. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 11, 2026.
Company Profile
This profile covers Somerset Medical Center IRB based in Somerville, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2016. Last inspected March 11, 2026.
Most cited issue areas
- Approval from a majority of members present1 inspection
- Conflict of interest1 inspection
- Copies of all research proposals and related documents1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 11, 2026 | Not classified | Biologics, Human Drugs, Medical Devices & Rad Health | 1306808 |
| September 30, 2016 | OAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 989881 |
FDA documents
EIRs (1)
People (2)
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Company Information
Name
Somerset Medical Center IRB
FEI Number
3012733828
Address
110 Rehill Ave, Somerville, New Jersey 08876, United States
Country
United States
ID: fe63c038-95e7-44c8-a93b-f49ec178685e