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Novartis Gene Therapies, Inc. — FDA Facility Profile

FEI 3012983541

Novartis Gene Therapies, Inc. is an FDA-inspected facility (FEI 3012983541) located in Libertyville, IL, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jun 16, 2021: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jun 16, 2021Voluntary Action Indicated (VAI)Procedures for sterile drug products (21 CFR 211.113(b))
Written specifications - components (21 CFR 212.40(b))
Complete test data included in records (21 CFR 211.194(a))
Deviations from laboratory control requirements (21 CFR 211.160(a))
and 1 more

Facility details

Company
Novartis Gene Therapies, Inc.
Location
Libertyville, IL (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.