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Novartis Pharmaceuticals S.R.L. — FDA Facility Profile

FEI 3005587283

Novartis Pharmaceuticals S.R.L. is an FDA-registered facility (FEI 3005587283) located in Romania (ROU). Registered operations: ANALYSIS; MANUFACTURE; PACK. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 11, 2025: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 VAI, 1 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
Jul 11, 2025Voluntary Action Indicated (VAI)No citations listed
Aug 26, 2023Voluntary Action Indicated (VAI)No citations listed
Nov 2, 2018Voluntary Action Indicated (VAI)No citations listed
Jan 15, 2015No Action Indicated (NAI)No citations listed

Facility details

Company
Novartis Pharmaceuticals S.R.L.
Location
Romania (ROU)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; MANUFACTURE; PACK
Source
decrs

FDA data resources

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