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Industrial Pesquera Santa Priscila S.A. (Factory 2) — FDA Facility Profile

FEI 3010798999

Industrial Pesquera Santa Priscila S.A. (Factory 2) is an FDA-inspected facility (FEI 3010798999) located in Guayaquil, EC. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 6, 2019: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 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
8

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 6, 2019Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))
Jun 9, 2014Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))
Critical limits (21 CFR 123.6(c)(3))

Facility details

Company
Industrial Pesquera Santa Priscila S.A. (Factory 2)
Location
Guayaquil (EC)
Source
inspections

Import refusals

FDA data resources

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