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Hans Zipperle, S.P.A. — FDA Facility Profile

FEI 1000595557

Hans Zipperle, S.P.A. is an FDA-inspected facility (FEI 1000595557) located in Merano, 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
Jun 4, 2019: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Jan 27, 2016
Warning letters
1 listed by FDA for this FEI, latest Sep 7, 2016

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
Jun 4, 2019Voluntary Action Indicated (VAI)HACCP plan - monitoring procedures not adequate (21 CFR 120.8(b)(4))
HACCP plan - critical limits not listed or not adequate (21 CFR 120.8(b)(3))
Jan 27, 2016Official Action Indicated (OAI)HACCP plan - critical control points not listed (21 CFR 120.8(b)(2))
Sanitation monitoring (21 CFR 120.6(b))

Facility details

Company
Hans Zipperle, S.P.A.
Location
Merano (IT)
Source
inspections

Compliance actions

FDA data resources

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