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JEIL MEDICAL CORPORATION — FDA Facility Profile

FEI 3004049923

JEIL MEDICAL CORPORATION is an FDA-registered facility (FEI 3004049923) located in Seoul, KR. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jan 23, 2014: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jan 23, 2014
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

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
Jan 23, 2014Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Design input - Lack of or inadequate procedures (21 CFR 820.30(c))
Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
and 10 more

Facility details

Company
Jeil Medical Corporation
Location
Seoul (KR)
Source
device

Import refusals

FDA data resources

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