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Sunshine International — FDA Facility Profile

FEI 3011388468

Sunshine International is an FDA-inspected facility (FEI 3011388468) located in Tha Mai, TH. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 10, 2016: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 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 10, 2016Voluntary Action Indicated (VAI)Drip and condensate (21 CFR 110.20(b)(4))
General inadequacy (21 CFR 110.37(a))
Readily accessible (21 CFR 110.37(d))
Feb 24, 2012Voluntary Action Indicated (VAI)Harborage areas (21 CFR 110.20(a)(1))
Screening (21 CFR 110.20(b)(7))
General inadequacy (21 CFR 110.37(a))
Maintained (21 CFR 110.37(d)(1))

Facility details

Company
Sunshine International
Location
Tha Mai (TH)
Source
inspections

FDA data resources

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