Company
United StatesAllendale IRB, Old Lyme, CT – FDA Inspections
Inspection records and compliance data for Allendale IRB in Old Lyme, Connecticut. 3 FDA inspections on record, last inspected March 19, 2020.
Company Profile
This profile covers Allendale IRB based in Old Lyme, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 23, 2011. Last inspected March 19, 2020.
Most cited issue areas
- Method to keep members advised2 inspections
- Continuing review1 inspection
- Copies of IRB/CI correspondence1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 19, 2020 | NAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 1122441 |
| September 24, 2015 | VAI | Biologics · Bioresearch Monitoring | 946552 |
| February 23, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 713978 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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IRB for the Baylor College of Medicine
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Company Information
Name
Allendale IRB
FEI Number
1000526912
Address
30 Neck Rd, Old Lyme, Connecticut 06371, United States
Country
United States
ID: 2a85fab3-818e-44ac-8d23-1749a2abb8f9