IMS GIOTTO S.P.A. — FDA Facility Profile

FEI 3002807317

IMS GIOTTO S.P.A. is an FDA-registered facility (FEI 3002807317) located in Sasso Marconi Bologna, IT. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Dec 4, 2014: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Dec 12, 2013
Warning letters
1 listed by FDA for this FEI, latest Apr 8, 2015

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
Dec 4, 2014No Action Indicated (NAI)No citations listed
Dec 12, 2013Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Lack of or inadequate procedures (21 CFR 820.100(a))
and 1 more

Facility details

Company
IMS GIOTTO S.P.A.
Location
Sasso Marconi Bologna (IT)
Source
device

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