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Procesadora Mejia S.A. — FDA Facility Profile

FEI 1000651812

Procesadora Mejia S.A. is an FDA-inspected facility (FEI 1000651812) located in Guayaquil, EC. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 6, 2019: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
1

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 6, 2019No Action Indicated (NAI)No citations listed
Apr 16, 2013No Action Indicated (NAI)No citations listed
Sep 20, 2011Voluntary Action Indicated (VAI)Initial temperature of container contents (21 CFR 113.87(c))
Evaluation by process authority (21 CFR 113.89)
Process deviation log/file (21 CFR 113.89)
Range, chart graduations (21 CFR 113.40(a)(2)(i))
and 4 more

Facility details

Company
Procesadora Mejia S.A.
Location
Guayaquil (EC)
Source
inspections

Import refusals

FDA data resources

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