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URSAPHARM Arzneimittel GmbH FDA Inspection Record

FEI 3004978466 · Inspections, Form 483s, warning letters and import refusals

URSAPHARM Arzneimittel GmbH is an FDA-registered facility (FEI 3004978466) located in Saarbrucken, DE. Registered operations: MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Oct 31, 2024: Voluntary Action Indicated (VAI)
Inspections on record
3 (2 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
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
Oct 31, 2024Voluntary Action Indicated (VAI)No citations listed
Sep 25, 2015No Action Indicated (NAI)No citations listed
Sep 13, 2013Voluntary Action Indicated (VAI)Procedures for sterile drug products (21 CFR 211.113(b))

Facility details

Company
Ursapharm Arzneimittel GmbH
Location
Saarbrucken (DE)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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