Procesadora San Martin De Porres FDA Inspection Record

FEI 3009999562 · Inspections, Form 483s, warning letters and import refusals

Procesadora San Martin De Porres is an FDA-inspected facility (FEI 3009999562) located in Santiago. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 13, 2016: 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
6

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 13, 2016Voluntary Action Indicated (VAI)Critical factors not stated (21 CFR 113.83)
Still steam retorts: Bleeder not wide open during process (21 CFR 113.40(a)(8))
Still Retorts: TID defective, could not be adjusted (21 CFR 113.40(a)(1)(iii))
Well bleeders - continuous steam emission (21 CFR 113.40(a)(1)(v))
and 3 more
Sep 27, 2011Voluntary Action Indicated (VAI)Non food-contact equipment in processing area (21 CFR 110.40(c))
Evaluation by process authority (21 CFR 113.89)
Before use and after interruption (21 CFR 110.35(d)(2))
Adjusted to agree with TID (21 CFR 113.40(g)(1)(i)(B)(3))
and 3 more
Aug 18, 2009Voluntary Action Indicated (VAI)Evaluation by process authority (21 CFR 113.89)
Process deviation log/file (21 CFR 113.89)
Buildings/good repair (21 CFR 110.35(a))
TID not accurately, easily read (21 CFR 113.40(a)(1)(v))
and 1 more

Facility details

Company
Procesadora San Martin De Porres
Location
Santiago
Source
inspections

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