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Daito Kasei Kogyo Co., Ltd. FDA Record

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

Latest inspection OAI · Jul 21, 2017
Last warning letter 2018

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jan 18, 2018

510(k) clearances 0 None on file

Daito Kasei Kogyo Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Daito Kasei Kogyo Co., Ltd., the most recent on Jan 18, 2018.

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

Latest inspection: Jul 21, 2017 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	1	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Daito Kasei Kogyo Co., Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	0	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.

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Daito Kasei Kogyo Co., Ltd. FDA Warning Letters

1 warning letter on Jan 18, 2018.

Issued	Subject	Issuing office	Close-out letter
Jan 18, 2018 · 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 Jul 21, 2017.

Date	Site	Product	Classification	FEI
Jul 21, 2017	Bizen, Japan	Drugs	Official Action Indicated (OAI)	1000223178

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 Daito Kasei Kogyo Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 18, 2018.

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 1000223178	Bizen, Japan	1	Jul 21, 2017

Daito Kasei Kogyo Co., Ltd. and the FDA: common questions

Has Daito Kasei Kogyo Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Daito Kasei Kogyo Co., Ltd.. The most recent is dated Jan 18, 2018.

Has Daito Kasei Kogyo Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Daito Kasei Kogyo Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Daito Kasei Kogyo Co., Ltd.?

The most recent FDA inspection on file ended Jul 21, 2017 at Bizen, Japan and was classified OAI. FDA has 1 inspection of Daito Kasei Kogyo Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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