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HANSOL MEDICAL CO. FDA Inspection Record

FEI 3005417950 · Inspections, Form 483s, warning letters and import refusals

HANSOL MEDICAL CO. is an FDA-registered facility (FEI 3005417950) located in PAJU-SI Gyeonggi, KR. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Nov 9, 2017: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
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
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
Nov 9, 2017Voluntary Action Indicated (VAI)No citations listed
Jul 31, 2014No Action Indicated (NAI)DHR - not or inadequately maintained (21 CFR 820.184)
Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
and 3 more

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

1 record behind this number
RecordDatePoints x age weightAdds
Inspection classified VAINov 9, 20176 x 0.251.5

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Hansol Medical
Location
PAJU-SI Gyeonggi (KR)
Source
device

Import refusals

FDA data resources

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