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Yuki Gosei Kogyo Co., Ltd.

FDA Regulatory Profile

Yuki Gosei Kogyo Co., Ltd. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 2 compliance actions on record.

What these totals cover: FDA records filed under the name "Yuki Gosei Kogyo Co., Ltd." and its spelling variant "Yuki Gosei Kogyo Co".

Latest inspection: Feb 6, 2026 · 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	7	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Yuki Gosei Kogyo 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	1	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	1	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	1
2017	1	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

7 inspections from Jul 21, 2010 to Feb 6, 2026.

Date	Site	Product	Classification	FEI
Feb 6, 2026	Iwaki, Japan	Drugs	Voluntary Action Indicated (VAI)	3002808534
Jul 28, 2021	Iwaki, Japan	Drugs	Voluntary Action Indicated (VAI)	3002808534
Nov 17, 2017	Iwaki, Japan	Drugs	Official Action Indicated (OAI)	3002808534
Sep 2, 2016	Iwaki, Japan	Drugs	Voluntary Action Indicated (VAI)	3002808534
Mar 7, 2014	Iwaki, Japan	Drugs	No Action Indicated (NAI)	3002808534
Jun 22, 2012	Iwaki, Japan	Drugs	Voluntary Action Indicated (VAI)	3002808534
Jul 21, 2010	Iwaki, Japan	Drugs	Official Action Indicated (OAI)	3002808534

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 2 compliance actions under Yuki Gosei Kogyo Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 17, 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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002808534	Iwaki, Japan	7	Feb 6, 2026

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