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KEUM HAN Industrial FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection OAI · Feb 18, 2020
Last warning letter 2020

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest May 19, 2020

510(k) clearances 0 None on file

KEUM HAN Industrial has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to KEUM HAN Industrial, the most recent on May 19, 2020.

What these totals cover: FDA records filed under the name "KEUM HAN Industrial".

Latest inspection: Feb 18, 2020 · OAI

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	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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KEUM HAN Industrial FDA Warning Letters

1 warning letter on May 19, 2020.

Issued	Subject	Issuing office	Close-out letter
May 19, 2020 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

1 inspection on Feb 18, 2020.

Date	Site	Product	Classification	FEI
Feb 18, 2020	Gangreung-Si, Korea (The Republic Of)	Food/Cosmetics	Official Action Indicated (OAI)	3011198967

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 KEUM HAN Industrial: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 19, 2020.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3011198967	Gangreung-Si, Korea (The Republic Of)	1	Feb 18, 2020

KEUM HAN Industrial and the FDA: common questions

Has KEUM HAN Industrial received an FDA warning letter?

Yes. FDA has issued 1 warning letter to KEUM HAN Industrial. The most recent is dated May 19, 2020.

Has KEUM HAN Industrial received an FDA Form 483?

FDA has not published a Form 483 for "KEUM HAN Industrial" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect KEUM HAN Industrial?

The most recent FDA inspection on file ended Feb 18, 2020 at Gangreung-Si, Korea (The Republic Of) and was classified OAI. FDA has 1 inspection of KEUM HAN Industrial on file, 1 of them classified OAI (official action indicated).

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