Novartis Pharmaceuticals Corporation — FDA Facility Profile

FEI 3000215618

Novartis Pharmaceuticals Corporation is an FDA-inspected facility (FEI 3000215618) located in Vacaville, CA, US. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Nov 2, 2012: Voluntary Action Indicated (VAI)
Inspections on record
7 (3 VAI, 4 NAI)
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
Nov 2, 2012Voluntary Action Indicated (VAI)No citations listed
Jul 18, 2011No Action Indicated (NAI)No citations listed
May 12, 2011Voluntary Action Indicated (VAI)No citations listed
Aug 27, 2010No Action Indicated (NAI)No citations listed
Dec 10, 2009No Action Indicated (NAI)No citations listed
May 13, 2009No Action Indicated (NAI)No citations listed
Feb 5, 2009Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Records reviewed annually (21 CFR 211.180(e))
Items to cover on annual reviews (21 CFR 211.180(e)(2))
Suitability of testing methods verified (21 CFR 211.194(a)(2))

Facility details

Company
Novartis Pharmaceuticals Corporation
Location
Vacaville, CA (US)
Source
inspections

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