Home / Countries / South Korea

FDA Inspections, Warning Letters and Import Refusals: South Korea

FDA has recorded 0 inspections of firms in South Korea, 0 of them (0%) classified OAI. It has issued 102 warning letters to firms there and refused 14,819 import shipments. 0 firms in South Korea are named on FDA import alerts.

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.

All countries · Check one supplier with the free FDA compliance check.

By year

The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.

South Korea: FDA import refusals per year 2017: 629 import refusals62920172018: 503 import refusals50320182019: 472 import refusals47220192020: 593 import refusals59320202021: 436 import refusals43620212022: 526 import refusals52620222023: 512 import refusals51220232024: 556 import refusals55620242025: 670 import refusals67020252026: 1,076 import refusals1,0762026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20260031,076
2025006670
2024008556
2023009512
2022003526
2021002436
2020007593
2019004472
20180011503
2017007629

Latest OAI inspections

No OAI inspections are recorded for firms in South Korea.

Latest warning letters

DateFirmProduct typeFDA center
Oct 2, 2026Hanlim Pharm Co. Ltd.DrugsCDER
Jun 15, 2026Huons Co., Ltd.DrugsCDER
May 4, 2026IDO PHARMDrugsCDER
Nov 12, 2025Sinsin Pharmaceutical Co., Ltd.DrugsCDER
Nov 3, 2025Koreafillerexperts.ComDrugsCDER
Jul 18, 2025Janssen Vaccines Corp.DrugsCDER
Jun 26, 2025Daewoo Pharmaceutical Co., Ltd.DrugsCDER
May 21, 2025Aju Medical Co., Ltd.DevicesCDRH
Jan 16, 2025Yongdae Hwangtae Union Corp DaeryungFood/CosmeticsCFSAN
Nov 22, 2024LCC Ltd.DrugsCDER
Nov 6, 2024Eden F&C, Co., Ltd.Food/CosmeticsCFSAN
Sep 25, 2024Outin Futures CorpDrugsCDER
Jun 26, 2024Rebom Co., Ltd.DrugsCDER
Jun 12, 2024Aqualex Co., Ltd.DrugsCDER
May 3, 2024Natuzen Co., Ltd.DrugsCDER
Apr 11, 2024C&T Dream Co., Ltd.DrugsCDER
Apr 4, 2024FirstCham Co., Ltd.DrugsCDER
Dec 28, 2023Woori Life & HealthDrugsCDER
Oct 4, 2023Handock Cosmetics Co., Ltd.DrugsCDER
Oct 2, 2023Seoul Cosmetics Co., Ltd.DrugsCDER
Aug 23, 2023Green Pharmaceutical Co., Ltd.DrugsCDER
Aug 14, 2023K.Boeun Pharmaceutical Co.,Ltd.DrugsCDER
Aug 3, 2023KM PHARMACEUTICAL CO., LTD.DrugsCDER
Aug 3, 2023LCC Ltd.DrugsCDER
Aug 3, 2023Sangleaf Pharm., Co LtdDrugsCDER

Showing the latest 25 of 102.

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Oct 22, 2026SID MEDICOS CO LTDCosmetics
Oct 22, 2026REANZEN CO LTDDevices
Oct 22, 2026BNC GlobalDrugs and Biologics
Oct 22, 2026SJM COSMETIC CO., LTDCosmetics
Oct 22, 2026HUGEL CO LTDDrugs and Biologics
Oct 22, 2026DAEHAN NEW PHARMDrugs and Biologics
Oct 22, 2026BNC GlobalDrugs and Biologics
Oct 22, 2026JEIL TECH CO LTDDevices
Oct 22, 2026Daewoong Pharmaceutical Co. Ltd. (Hyangnam Factory)Drugs and Biologics
Oct 22, 2026JETEMA CO LTDDevices
Oct 22, 2026Exocobio, Inc.Devices
Oct 22, 2026SOUTH KOREAN SUNGSHIM MEDICAL CODevices
Oct 22, 2026GDK Cosmetics Co., Ltd.Drugs and Biologics
Oct 22, 2026Dongbang Medical Co. LtdDevices
Oct 22, 2026Dongbang Medical Co. LtdDevices
Oct 22, 2026Across Co., LtdDevices
Oct 21, 2026ERIC EVANSDevices
Oct 20, 2026Seoul Cosmetics Co., Ltd.Cosmetics
Oct 20, 2026Seoul Cosmetics Co., Ltd.Cosmetics
Oct 19, 2026Seoul Cosmetics Co., Ltd.Cosmetics
Oct 19, 2026UCLCosmetics
Oct 19, 2026Seoul Cosmetics Co., Ltd.Cosmetics
Oct 19, 2026Seoul Cosmetics Co., Ltd.Cosmetics
Oct 19, 2026Seoul Cosmetics Co., Ltd.Cosmetics
Oct 19, 2026Seoul Cosmetics Co., Ltd.Cosmetics

Showing the latest 25 of 14,819.

See every import refusal from South Korea.

Firms on FDA import alerts

No firms in South Korea are recorded on FDA import alerts.

Most-inspected facilities

No inspected facilities are recorded in South Korea.

See each facility's Form 483 observations with the FDA 483 search.

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