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INSUNG MEDICAL CO., LTD. FDA Inspection Record

FEI 3013023209 · Inspections, Form 483s, warning letters and import refusals

INSUNG MEDICAL CO., LTD. is an FDA-registered facility (FEI 3013023209) located in WONJU-SI Gangwon, KR. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 1, 2025: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
May 1, 2025
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 1, 2025Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Devices subject to device identification GUDID data submission requirements. (21 CFR 830.300(a))
Design input - documentation (21 CFR 820.30(c))
Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b))
and 2 more

Facility details

Company
INSUNG MEDICAL CO LTD
Location
WONJU-SI Gangwon (KR)
Source
device

FDA data resources

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