Company
United StatesSpectrum Health Institutional Review Board, Grand Rapids, MI – FDA Inspections
Inspection records and compliance data for Spectrum Health Institutional Review Board in Grand Rapids, Michigan. 3 FDA inspections on record, last inspected March 05, 2018.
Company Profile
This profile covers Spectrum Health Institutional Review Board based in Grand Rapids, Michigan, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 9, 2009. Last inspected March 5, 2018.
Most cited issue areas
- Prompt reporting of noncompliance1 inspection
- Written procedures per 56.108(a) and (b)1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 5, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1044859 |
| September 17, 2014 | VAI | Biologics · Bioresearch Monitoring | 897010 |
| November 9, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 628536 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
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University of Tennessee Graduate School of Medicine IRB
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Company Information
Name
Spectrum Health Institutional Review Board
FEI Number
1824967
Address
15 Michigan St Ne Ste 750, Grand Rapids, Michigan 49503, United States
Country
United States
ID: 16b535c6-bd70-4eaa-9ea4-f82c58a274dc