Company
United StatesOriGen Biomedical, Inc., Austin, TX – FDA Inspections
Inspection records and compliance data for OriGen Biomedical, Inc. in Austin, Texas. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 08, 2020.
Company Profile
This profile covers OriGen Biomedical, Inc. based in Austin, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 26, 2013. Last inspected January 8, 2020.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 8, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1115852 |
| July 5, 2018 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1059095 |
| April 26, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 828408 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
OriGen Biomedical, Inc.
FEI Number
1000160256
Address
7000 Burleson Rd Bldg D, Austin, Texas 78744, United States
Country
United States
ID: 6d4f9178-e02c-4ba8-9820-40f0fb5d7080