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SPATZ FGIA INC. — FDA Facility Profile

FEI 3015409025

SPATZ FGIA INC. is an FDA-registered facility (FEI 3015409025) located in Ra'anana Central, IL. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 15, 2022: No Action Indicated (NAI)
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
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
Dec 15, 2022No Action Indicated (NAI)No citations listed
Sep 25, 2019Voluntary Action Indicated (VAI)No citations listed
Aug 9, 2019Voluntary Action Indicated (VAI)Sponsors' general responsibilities (21 CFR 812.40)

Facility details

Company
Spatz FGIA, Inc
Location
Ra'anana Central (IL)
Source
device

Import refusals

FDA data resources

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