Grupo Pozuelo & PRO GPP, S.A. — FDA Facility Profile

FEI 3004286612

Grupo Pozuelo & PRO GPP, S.A. is an FDA-inspected facility (FEI 3004286612) located in Ciudad Colon, CR. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 29, 2023: Voluntary Action Indicated (VAI)
Inspections on record
3 (3 VAI)
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
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
Jun 29, 2023Voluntary Action Indicated (VAI)Hazard analysis - Identification of hazard (21 CFR 117.130(a)(1))
Apr 19, 2017Voluntary Action Indicated (VAI)Precautions against contamination--micro, foreign substances (21 CFR 110.10(b)(9))
Storage (21 CFR 110.80(a)(1))
Nov 16, 2012Voluntary Action Indicated (VAI)Materials and workmanship (21 CFR 110.40(a))
Buildings/sanitary (21 CFR 110.35(a))
Storage requirements (21 CFR 110.35(b)(2))
Running water at suitable temperature (21 CFR 110.37(e))
and 3 more

Facility details

Company
Grupo Pozuelo & PRO GPP, S.A.
Location
Ciudad Colon (CR)
Source
inspections

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