Company
United StatesBioEden Inc, Austin, TX – FDA Inspections
Inspection records and compliance data for BioEden Inc in Austin, Texas. 2 FDA inspections on record, 1 Form 483, last inspected July 19, 2018.
Company Profile
This profile covers BioEden Inc based in Austin, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected January 18, 2012. Last inspected July 19, 2018.
Most cited issue areas
- Environmental Monitoring System1 inspection
- Expiration date lacking1 inspection
- Prepared for each batch, include complete information1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 19, 2018 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1059476 |
| January 18, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 763386 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BioEden Inc
FEI Number
3005877419
Address
11629 Menchaca Rd Ste C, Austin, Texas 78748, United States
Country
United States
ID: 710d6615-338c-4981-986b-45dcb74e3190