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AGUPUNT USA Corp. — FDA Facility Profile

FEI 3029983589

AGUPUNT USA Corp. is an FDA-registered facility (FEI 3029983589) located in Coral Gables, FL, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Mar 25, 2026: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 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

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
Mar 25, 2026Voluntary Action Indicated (VAI)Purchased product verification activities not established or implemented (ISO 13485:2016 Clause 7.4.3)
Info evaluated to determine if event was reportable (21 CFR 803.17(b)(1))

Facility details

Company
Agupunt USA Corp
Location
Coral Gables, FL (US)
Source
device

FDA data resources

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