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NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) — FDA Facility Profile

FEI 3009904675

NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA) is an FDA-inspected facility (FEI 3009904675) located in Guayaquil, EC. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Nov 11, 2016: No Action Indicated (NAI)
Inspections on record
4 (1 OAI, 2 VAI, 1 NAI)
Last OAI inspection
Aug 10, 2011
Warning letters
1 listed by FDA for this FEI, latest Jan 23, 2012
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
Nov 11, 2016No Action Indicated (NAI)No citations listed
Apr 9, 2013Voluntary Action Indicated (VAI)No citations listed
Aug 10, 2011Official Action Indicated (OAI)No citations listed
Jan 20, 2009Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))

Facility details

Company
NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA)
Location
Guayaquil (EC)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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