Novartis Pharma Produktions GmbH — FDA Facility Profile

FEI 3000978864

Novartis Pharma Produktions GmbH is an FDA-registered facility (FEI 3000978864) located in Wehr, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 11, 2024: Voluntary Action Indicated (VAI)
Inspections on record
6 (2 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
Import refusals
10 or more

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, 2024Voluntary Action Indicated (VAI)No citations listed
Sep 27, 2019No Action Indicated (NAI)No citations listed
May 19, 2017No Action Indicated (NAI)No citations listed
Jun 18, 2015No Action Indicated (NAI)No citations listed
Jun 24, 2013No Action Indicated (NAI)No citations listed
Sep 15, 2011Voluntary Action Indicated (VAI)Review of representative number of batches (21 CFR 211.180(e)(1))
Complaint Handling Procedure (21 CFR 211.198(a))

Facility details

Company
Novartis Pharma Produktions GmbH
Location
Wehr (DE)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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