MERCK SERONO SPA — FDA Facility Profile

FEI 3002807252

MERCK SERONO SPA is an FDA-registered facility (FEI 3002807252) located in Roma, IT. Registered operations: ANALYSIS. RegDataLab tracks 7 FDA inspections and 1 compliance action 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
7 (1 OAI, 3 VAI, 3 NAI)
Last OAI inspection
Jul 1, 2011
Warning letters
1 listed by FDA for this FEI, latest Dec 15, 2011
Import refusals
2

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
Mar 29, 2019Voluntary Action Indicated (VAI)No citations listed
Jul 28, 2017No Action Indicated (NAI)No citations listed
Feb 20, 2015No Action Indicated (NAI)No citations listed
Mar 14, 2013Voluntary Action Indicated (VAI)No citations listed
Jul 1, 2011Official Action Indicated (OAI)No citations listed
Apr 30, 2009No Action Indicated (NAI)No citations listed

Facility details

Company
Merck Serono S.P.A.
Location
Roma (IT)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS
Source
decrs

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