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ALFASIGMA SPA — FDA Facility Profile

FEI 3003911081

ALFASIGMA SPA is an FDA-registered facility (FEI 3003911081) located in ALANNO, PE, IT. Registered operations: MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 27, 2022: Voluntary Action Indicated (VAI)
Inspections on record
3 (3 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
Import refusals
8

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
Sep 27, 2022Voluntary Action Indicated (VAI)No citations listed
Jan 18, 2019Voluntary Action Indicated (VAI)No citations listed
Jul 3, 2015Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Alfasigma SPA
Location
ALANNO, PE (IT)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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