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Skybio Co.,Ltd. — FDA Facility Profile

FEI 3012911313

Skybio Co.,Ltd. is an FDA-inspected facility (FEI 3012911313) located in Geochang. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Sep 12, 2023: 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
Import refusals
1

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
Sep 12, 2023Voluntary Action Indicated (VAI)Critical control points (21 CFR 123.6(c)(2))

Facility details

Company
Skybio Co.,Ltd.
Location
Geochang
Source
inspections

Import refusals

FDA data resources

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