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Sociedad Guidomar Ltda — FDA Facility Profile

FEI 3008845581

Sociedad Guidomar Ltda is an FDA-inspected facility (FEI 3008845581) located in Coquimbo, CL. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
May 23, 2014: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
May 23, 2014
Warning letters
1 listed by FDA for this FEI, latest Nov 24, 2014
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 23, 2014Official Action Indicated (OAI)Sanitation monitoring (21 CFR 123.11(b))
Corrective action per predetermined plan (21 CFR 123.7(a))
Critical limits (21 CFR 123.6(c)(3))

Facility details

Company
Sociedad Guidomar Ltda
Location
Coquimbo (CL)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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