GRUPO 15 INTERNATIONAL, LLC. FDA Record

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

GRUPO 15 INTERNATIONAL, LLC. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GRUPO 15 INTERNATIONAL, LLC." is on file.

What these totals cover: FDA records filed under the name "GRUPO 15 INTERNATIONAL, LLC." and its spelling variant "Grupo 15 International".

Latest inspection
Dec 7, 2022 · VAI

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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Dec 7, 2022.

DateSiteProductClassificationFEI
Dec 7, 2022Hidalgo, TXFood/CosmeticsVoluntary Action Indicated (VAI)3013694688
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 3013694688Hidalgo, TX1Dec 7, 2022

GRUPO 15 INTERNATIONAL, LLC. and the FDA: common questions

Has GRUPO 15 INTERNATIONAL, LLC. received an FDA warning letter?

No FDA warning letter addressed to the name "GRUPO 15 INTERNATIONAL, LLC." 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 GRUPO 15 INTERNATIONAL, LLC. received an FDA Form 483?

FDA has not published a Form 483 for "GRUPO 15 INTERNATIONAL, LLC." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect GRUPO 15 INTERNATIONAL, LLC.?

The most recent FDA inspection on file ended Dec 7, 2022 at Hidalgo, TX and was classified VAI. FDA has 1 inspection of GRUPO 15 INTERNATIONAL, LLC. on file.

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