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DULCOR S.A. — FDA Facility Profile

FEI 3004264417

DULCOR S.A. is an FDA-inspected facility (FEI 3004264417) located in Arroyito, AR. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 13, 2015: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
May 13, 2015
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
May 13, 2015Official Action Indicated (OAI)Supervisors (21 CFR 113.10)
Screening (21 CFR 110.20(b)(7))
Frequency: visual closure examinations, record (21 CFR 113.60(a))
Recording of teardown examinations (21 CFR 113.60(a)(1))
and 1 more

Facility details

Company
DULCOR S.A.
Location
Arroyito (AR)
Source
inspections

Import refusals

FDA data resources

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