Company
United StatesNovartis Gene Therapies, Inc., Libertyville, IL – FDA Inspections
Inspection records and compliance data for Novartis Gene Therapies, Inc. in Libertyville, Illinois. 2 FDA inspections on record, 1 Form 483, last inspected June 16, 2021.
Company Profile
This profile covers Novartis Gene Therapies, Inc. based in Libertyville, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 8, 2019. Last inspected June 16, 2021.
Most cited issue areas
- Complete test data included in records1 inspection
- Deviations from laboratory control requirements1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 16, 2021 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1144535 |
| February 8, 2019 | Not classified | Biologics | 1086650 |
FDA documents
Form 483s (2)
EIRs (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Novartis Gene Therapies, Inc.
FEI Number
3012983541
Address
1940 Usg Dr, Libertyville, Illinois 60048, United States
Country
United States
ID: 58c140f1-7389-4053-a757-b61650a3a86a