Company
United StatesCook General BioTechnology, LLC, Indianapolis, IN – FDA Inspections
Inspection records and compliance data for Cook General BioTechnology, LLC in Indianapolis, Indiana. 4 FDA inspections on record, last inspected March 08, 2018.
Company Profile
This profile covers Cook General BioTechnology, LLC based in Indianapolis, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected December 20, 2010. Last inspected March 8, 2018.
Most cited issue areas
- Donors with risks not determined ineligible2 inspections
- Completion of eligibility determination1 inspection
- Contamination, mix ups, improper release1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 8, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1049254 |
| March 10, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 963325 |
| January 12, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 763384 |
| December 20, 2010 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 702541 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cook General BioTechnology, LLC
FEI Number
3004976934
Address
1102 Indiana Ave, Indianapolis, Indiana 46202, United States
Country
United States
ID: 07b8c672-7e5a-46d7-b217-117781d094cd