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Wakka USA Inc — FDA Facility Profile

FEI 3012953061

Wakka USA Inc is an FDA-inspected facility (FEI 3012953061) located in Honolulu, HI, US. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 23, 2023: Voluntary Action Indicated (VAI)
Inspections on record
3 (3 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
May 23, 2023Voluntary Action Indicated (VAI)Hazard analysis biological, chemical, physical (21 CFR 1.504(b)(1))
Evaluation - performance, risk (21 CFR 1.505(a)(2))
Approved supplier procedures - importer established (21 CFR 1.506(a)(1))
Feb 1, 2021Voluntary Action Indicated (VAI)Develop FSVP (21 CFR 1.502(a))
Dec 21, 2018Voluntary Action Indicated (VAI)Develop FSVP (21 CFR 1.502(a))

Facility details

Company
Wakka USA Inc
Location
Honolulu, HI (US)
Source
inspections

FDA data resources

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