Productos Alimenticios Centroamericanos, S.A. — FDA Facility Profile

FEI 3003314477

Productos Alimenticios Centroamericanos, S.A. is an FDA-inspected facility (FEI 3003314477) located in San Miguel Petapa, GT. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jul 20, 2017: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Feb 12, 2013
Warning letters
1 listed by FDA for this FEI, latest Jul 1, 2013
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
Jul 20, 2017Voluntary Action Indicated (VAI)Scheduled processes not established (21 CFR 113.83)
Sanitary operations - Plant maintenance (21 CFR 117.35(a))
Pest control (21 CFR 117.35(c))
Equipment and utensils - Design and maintenance (21 CFR 117.40)
Feb 12, 2013Official Action Indicated (OAI)As source of contamination (21 CFR 110.37(b)(3))
Personnel (21 CFR 114.10)
Quality control procedures (21 CFR 114.80(a))
Scheduled process (21 CFR 114.80(a)(1))
and 1 more

Facility details

Company
Productos Alimenticios Centroamericanos, S.A.
Location
San Miguel Petapa (GT)
Source
inspections

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