Company
United StatesCook Childrens Health Care System IRB, Fort Worth, TX – FDA Inspections
Inspection records and compliance data for Cook Childrens Health Care System IRB in Fort Worth, Texas. 3 FDA inspections on record, last inspected December 11, 2025.
Company Profile
This profile covers Cook Childrens Health Care System IRB based in Fort Worth, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2012. Last inspected December 11, 2025.
Most cited issue areas
- Copies of all research proposals and related documents1 inspection
- Emergency use and IRB approval1 inspection
- Initial and continuing reviews1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2025 | Not classified | Biologics, Human Drugs, Medical Devices & Rad Health | 1295922 |
| May 3, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1092998 |
| February 3, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 766942 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cook Childrens Health Care System IRB
FEI Number
1640975
Address
1500 W Rosedale St, Fort Worth, Texas 76104, United States
Country
United States
ID: 2ce13f5a-e943-4b8f-bf7c-22e4fc1d1f02