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Constanza Agroindustrial SRL — FDA Facility Profile

FEI 3004262720

Constanza Agroindustrial SRL is an FDA-inspected facility (FEI 3004262720) located in Santo Domingo Oeste. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Sep 22, 2017: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Dec 4, 2012
Warning letters
1 listed by FDA for this FEI, latest Jun 6, 2013
Import refusals
5

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
Sep 22, 2017Voluntary Action Indicated (VAI)Scheduled process (21 CFR 114.80(a)(1))
pH testing (21 CFR 114.80(a)(2))
Scheduled process establishment (21 CFR 114.83)
Dec 4, 2012Official Action Indicated (OAI)No citations listed

Facility details

Company
Constanza Agroindustrial SRL
Location
Santo Domingo Oeste
Source
inspections

Compliance actions

Import refusals

FDA data resources

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