Company
United StatesSaint Elizabeth Med Ctr IRB, Edgewood, KY – FDA Inspections
Inspection records and compliance data for Saint Elizabeth Med Ctr IRB in Edgewood, Kentucky. 2 FDA inspections on record, last inspected March 09, 2016.
Company Profile
This profile covers Saint Elizabeth Med Ctr IRB based in Edgewood, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 3, 2010. Last inspected March 9, 2016.
Most cited issue areas
- IRB for CI"s in support of research/marketing permits1 inspection
- Reporting1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 9, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 961091 |
| May 3, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 655819 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Saint Elizabeth Med Ctr IRB
FEI Number
3000209922
Address
1 Medical Village Dr, Edgewood, Kentucky 41017, United States
Country
United States
ID: c7eb6852-b155-4cae-9379-673c998a69af