Company
United StatesLutheran Hospital IRB, Fort Wayne, IN – FDA Inspections
Inspection records and compliance data for Lutheran Hospital IRB in Fort Wayne, Indiana. 2 FDA inspections on record, last inspected May 10, 2013.
Company Profile
This profile covers Lutheran Hospital IRB based in Fort Wayne, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 23, 2010. Last inspected May 10, 2013.
Most cited issue areas
- Factors required for approval1 inspection
- Minutes of IRB meetings1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 10, 2013 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 834002 |
| February 23, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 649224 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lutheran Hospital IRB
FEI Number
1827503
Address
7950 W Jefferson Blvd, Fort Wayne, Indiana 46804, United States
Country
United States
ID: 54a1debe-f9f0-448c-a1d2-90dd22cdcf2c