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DCOOP. S.COOP. AND. — FDA Facility Profile

FEI 3008987443

DCOOP. S.COOP. AND. is an FDA-inspected facility (FEI 3008987443) located in Monturque, ES. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 12, 2016: No Action Indicated (NAI)
Inspections on record
3 (1 OAI, 2 NAI)
Last OAI inspection
Sep 19, 2013
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
3

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
Apr 12, 2016No Action Indicated (NAI)No citations listed
Dec 4, 2014No Action Indicated (NAI)No citations listed
Sep 19, 2013Official Action Indicated (OAI)Initial temperature of container contents (21 CFR 113.87(c))
Critical factors not stated (21 CFR 113.83)
Operating processes not posted (21 CFR 113.87(a))
Other systems - records; critical factors (21 CFR 113.100(a)(7))
and 5 more

Facility details

Company
DCOOP. S.COOP. AND.
Location
Monturque (ES)
Source
inspections

Import refusals

FDA data resources

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