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Nippon Fine Chemical Co., Ltd. FDA Record

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

Latest inspection VAI · Nov 14, 2025
Last warning letter 2016

Inspections 5

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 27, 2016

510(k) clearances 0 None on file

Nippon Fine Chemical Co., Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Nippon Fine Chemical Co., Ltd., the most recent on Sep 27, 2016.

What these totals cover: FDA records filed under the name "Nippon Fine Chemical Co., Ltd." and its spelling variant "Nippon Fine Chemical Co".

Latest inspection: Nov 14, 2025 · VAI

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

FDA record by year

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

Nippon Fine Chemical Co., Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	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.

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Nippon Fine Chemical Co., Ltd. FDA Warning Letters

1 warning letter on Sep 27, 2016.

Issued	Subject	Issuing office	Close-out letter
Sep 27, 2016 · 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

5 inspections from Jun 24, 2010 to Nov 14, 2025.

Date	Site	Product	Classification	FEI
Nov 14, 2025	Takasago, Japan	Drugs	Voluntary Action Indicated (VAI)	3001722961
Jun 11, 2019	Takasago, Japan	Drugs	Voluntary Action Indicated (VAI)	3001722961
Jan 31, 2017	Takasago, Japan	Drugs	Voluntary Action Indicated (VAI)	3001722961
Dec 17, 2015	Takasago, Japan	Drugs	Official Action Indicated (OAI)	3001722961
Jun 24, 2010	Takasago, Japan	Drugs	Voluntary Action Indicated (VAI)	3001722961

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 Nippon Fine Chemical Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 27, 2016.

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 3001722961	Takasago, Japan	5	Nov 14, 2025

Nippon Fine Chemical Co., Ltd. and the FDA: common questions

Has Nippon Fine Chemical Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Nippon Fine Chemical Co., Ltd.. The most recent is dated Sep 27, 2016.

Has Nippon Fine Chemical Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Nippon Fine Chemical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Nippon Fine Chemical Co., Ltd.?

The most recent FDA inspection on file ended Nov 14, 2025 at Takasago, Japan and was classified VAI. FDA has 5 inspections of Nippon Fine Chemical Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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