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ARKYO INTERNATIONAL INC FDA Inspection Record

FEI 3016341556 · Inspections, Form 483s, warning letters and import refusals

ARKYO INTERNATIONAL INC is an FDA-inspected facility (FEI 3016341556) located in Catano, PR, US. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 28, 2025: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 NAI)
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
Apr 28, 2025No Action Indicated (NAI)No citations listed
Apr 21, 2023No Action Indicated (NAI)No citations listed
Apr 22, 2022Voluntary Action Indicated (VAI)Develop FSVP (21 CFR 1.502(a))

Facility details

Company
ARKYO INTERNATIONAL INC
Location
Catano, PR (US)
Source
inspections

FDA data resources

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