Cosmo SpA FDA Inspection Record

FEI 3004504760 ยท Inspections, Form 483s, warning letters and import refusals

Cosmo SpA is an FDA-registered facility (FEI 3004504760) located in MILANO, IT. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 31, 2025: Voluntary Action Indicated (VAI)
Inspections on record
6 (4 VAI, 2 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
1

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
Jan 31, 2025Voluntary Action Indicated (VAI)No citations listed
Nov 11, 2022Voluntary Action Indicated (VAI)No citations listed
Feb 2, 2018Voluntary Action Indicated (VAI)No citations listed
Jul 8, 2015Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Adequate number of batches on stability (21 CFR 211.166(b))
Jul 18, 2013No Action Indicated (NAI)No citations listed
Nov 11, 2011No Action Indicated (NAI)No citations listed

Facility details

Company
Cosmo S.P.A.
Location
MILANO (IT)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
decrs

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