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Kolmar Korea Co. Ltd.

FDA Regulatory Profile

Kolmar Korea Co. Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Kolmar Korea Co. Ltd." and its spelling variant "Kolmar Korea Co".

Latest inspection: Feb 16, 2024 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	6	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Kolmar Korea Co. Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	1	0	0
2023	0	0	0
2022	1	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	1
2017	2	1	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

6 inspections from Jul 12, 2013 to Feb 16, 2024.

Date	Site	Product	Classification	FEI
Feb 16, 2024	Sejong, Korea (The Republic Of)	Drugs	Voluntary Action Indicated (VAI)	3010299845
Jul 7, 2022	Sejong, Korea (The Republic Of)	Drugs	Voluntary Action Indicated (VAI)	3010299845
Sep 28, 2017	Sejong, Korea (The Republic Of)	Drugs	Official Action Indicated (OAI)	3004033751
Sep 15, 2017	Sejong, Korea (The Republic Of)	Drugs	Voluntary Action Indicated (VAI)	3010299845
Apr 3, 2015	Sejong, Korea (The Republic Of)	Drugs	Voluntary Action Indicated (VAI)	3004033751
Jul 12, 2013	Sejong, Korea (The Republic Of)	Drugs	Voluntary Action Indicated (VAI)	3004033751

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Kolmar Korea Co. Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 18, 2018.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3010299845	Sejong, Korea (The Republic Of)	3	Feb 16, 2024
FEI 3004033751	Sejong, Korea (The Republic Of)	3	Sep 28, 2017

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