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Thai Nippon Rubber Industry Co., Ltd.

FDA Regulatory Profile

Thai Nippon Rubber Industry Co., Ltd. has 0 FDA recalls, 2 inspections, 6 510(k) clearances and 1 compliance action on record.

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

Latest inspection: Mar 17, 2016 · VAI
Latest 510(k): Jul 30, 2015

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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	6	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

2 inspections from May 14, 2015 to Mar 17, 2016.

Date	Site	Product	Classification	FEI
Mar 17, 2016	Si Racha, Thailand	Devices	Voluntary Action Indicated (VAI)	3008808138
May 14, 2015	Si Racha, Thailand	Devices	Official Action Indicated (OAI)	3008808138

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

Most recent: Warning Letter, Sep 14, 2015.

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 3008808138	Si Racha, Thailand	2	Mar 17, 2016

Recent 510(k) clearances

6 510(k) clearances from Jan 18, 2000 to Jul 30, 2015.

K-Number	Device	Date
K142790	OneTouch Lubricant Gel	Jul 30, 2015
K081265	THAI NIPPON MALE LATEX CONDOM	Oct 16, 2009
K032909	THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM	Dec 16, 2003
K011253	FLAVORED MALE LATEX CONDOM	Jul 20, 2001
K001978	'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9	Aug 8, 2000
K994095	LATEX CONDOM	Jan 18, 2000

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