Company
United StatesNovartis Gene Therapies, Inc., San Diego, CA – FDA Inspections
Inspection records and compliance data for Novartis Gene Therapies, Inc. in San Diego, California. 3 FDA inspections on record, 1 Form 483, last inspected August 27, 2021.
Company Profile
This profile covers Novartis Gene Therapies, Inc. based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 15, 2019. Last inspected August 27, 2021.
Most cited issue areas
- Complete test data included in records1 inspection
- Following/documenting laboratory controls1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 27, 2021 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1155029 |
| August 2, 2019 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1098391 |
| February 15, 2019 | Not classified | Biologics | 1086318 |
FDA documents
EIRs (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Novartis Gene Therapies, Inc.
FEI Number
3014617030
Address
10210 Campus Point Dr Ste 300, San Diego, California 92121, United States
Country
United States
ID: 04406f28-2c1b-4c68-ab75-a9862bfc9169