Company
United StatesUniversity of Miami, Human Subjects Research Office, Medical IRB, Coral Gables, FL – FDA Inspections
Inspection records and compliance data for University of Miami, Human Subjects Research Office, Medical IRB in Coral Gables, Florida. 3 FDA inspections on record, last inspected April 21, 2016.
Company Profile
This profile covers University of Miami, Human Subjects Research Office, Medical IRB based in Coral Gables, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 12, 2011. Last inspected April 21, 2016.
Most cited issue areas
- Confidentiality, FDA inspection of records1 inspection
- Procedures, identification of those which were experimental1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 21, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 974530 |
| December 24, 2015 | VAI | Foods & Cosmetics · Bioresearch Monitoring | 955833 |
| January 12, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 706147 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
University of Miami, Human Subjects Research Office, Medical IRB
FEI Number
1044676
Address
1320 S Dixie Hwy Ste 650, Coral Gables, Florida 33146, United States
Country
United States
ID: 4cfada7e-c4f2-40f9-9dba-0814ad07a855