Novartis Gene Therapies, Inc. - Inspection Records

Inspection records and compliance data for Novartis Gene Therapies, Inc. in San Diego, California. 2 FDA inspections on record, 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: 2
OAI: 0
VAI: 2
NAI: 0
Form 483s: 0
Warning letters: 0

First inspected August 2, 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

Most recent inspections

Date	Classification	Office	Project area
August 27, 2021	VAI	Center for Biologics Evaluation and Research	Human Cellular, Tissue, and Gene Therapies
August 2, 2019	VAI	Center for Biologics Evaluation and Research	Human Cellular, Tissue, and Gene Therapies

Documents (7)

FDA Inspection 1155029 - Novartis Gene Therapies, Inc. - 2021-08-27

fda_inspection

483 - Novartis Gene Therapies, Inc. - 2021-08-23

483

483 - Novartis Gene Therapies, Inc. - 2019-08-02

483

OTHER_CORRESPONDENCE - Novartis Gene Therapies, Inc. - 2019-08-02

OTHER_CORRESPONDENCE

483 - Novartis Gene Therapies, Inc. - 2019-08-02

483

FDA Inspection 1098391 - Novartis Gene Therapies, Inc. - 2019-08-02

fda_inspection

EIR - Novartis Gene Therapies, Inc. - 2019-02-15

EIR

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