Frigolab San Mateo Cia. Ltda FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Frigolab San Mateo Cia. Ltda has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Frigolab San Mateo Cia. Ltda" is on file.

What these totals cover: FDA records filed under the name "Frigolab San Mateo Cia. Ltda".

Latest inspection
Jun 21, 2019 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

4 inspections from Apr 7, 2009 to Jun 21, 2019.

DateSiteProductClassificationFEI
Jun 21, 2019Jaramigo, EcuadorFood/CosmeticsNo Action Indicated (NAI)1000156635
Mar 12, 2015Jaramigo, EcuadorFood/CosmeticsNo Action Indicated (NAI)1000156635
Aug 23, 2011Jaramigo, EcuadorFood/CosmeticsVoluntary Action Indicated (VAI)1000156635
Apr 7, 2009Jaramigo, EcuadorFood/CosmeticsVoluntary Action Indicated (VAI)1000156635
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000156635Jaramigo, Ecuador4Jun 21, 2019

Frigolab San Mateo Cia. Ltda and the FDA: common questions

Has Frigolab San Mateo Cia. Ltda received an FDA warning letter?

No FDA warning letter addressed to the name "Frigolab San Mateo Cia. Ltda" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Frigolab San Mateo Cia. Ltda received an FDA Form 483?

FDA has not published a Form 483 for "Frigolab San Mateo Cia. Ltda" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Frigolab San Mateo Cia. Ltda?

The most recent FDA inspection on file ended Jun 21, 2019 at Jaramigo, Ecuador and was classified NAI. FDA has 4 inspections of Frigolab San Mateo Cia. Ltda on file.

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