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Empacadora Bilbo S.A.

FDA Regulatory Profile

Empacadora Bilbo S.A. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jul 28, 2023 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 28, 2023Montecristi, EcuadorFood/CosmeticsOfficial Action Indicated (OAI)3004290156
Oct 12, 2015Montecristi, EcuadorFood/CosmeticsVoluntary Action Indicated (VAI)3004290156
Apr 9, 2009Montecristi, EcuadorFood/CosmeticsNo Action Indicated (NAI)3004290156

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3004290156Montecristi, Ecuador3Jul 28, 2023

FDA data resources

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