Campo D"Oro S.R.L. — FDA Facility Profile

FEI 3004308807

Campo D"Oro S.R.L. is an FDA-inspected facility (FEI 3004308807) located in Sciacca, IT. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 20, 2016: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Jun 2, 2010
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

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 20, 2016Voluntary Action Indicated (VAI)Personnel (21 CFR 114.10)
Code - required elements (21 CFR 114.80(b))
Maintenance of processing and production records (21 CFR 114.100(b))
Suitable locations (21 CFR 110.37(e)(1))
Sep 23, 2011No Action Indicated (NAI)Harborage areas (21 CFR 110.20(a)(1))
Failure to wear (21 CFR 110.10(b)(6))
Adequate lighting (21 CFR 110.20(b)(5))
Sanitation Records (21 CFR 123.11(c))
and 7 more
Jun 2, 2010Official Action Indicated (OAI)No citations listed

Facility details

Company
Campo D"Oro S.R.L.
Location
Sciacca (IT)
Source
inspections

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