Company
United StatesTargeted Genomics, LLC, Irvine, CA – FDA Inspections
Inspection records and compliance data for Targeted Genomics, LLC in Irvine, CA. 1 FDA inspection on record, 1 Form 483, last inspected March 26, 2026.
Company Profile
This profile covers Targeted Genomics, LLC based in Irvine, CA, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected March 26, 2026.
Most cited issue areas
- Control over outsourced processes not proportionate to risk1 inspection
- Risk-based approach not applied to QMS processes1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 26, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1309576 |
FDA documents
Form 483s (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Targeted Genomics, LLC
FEI Number
3035380687
Address
5 Mason, Irvine, CA 92618-2552, United States
Country
United States
ID: e7cd5a9d-6cd7-42fb-9a35-53c9a23c1856