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Taiwan Three Mast Pharmaceutical Co., Ltd. FDA Record

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

Taiwan Three Mast Pharmaceutical 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 Taiwan Three Mast Pharmaceutical Co., Ltd., the most recent on Dec 18, 2012.

What these totals cover: FDA records filed under the name "Taiwan Three Mast Pharmaceutical Co., Ltd." and its spelling variant "Taiwan Three Mast Pharmaceutical Co".

Latest inspection: Apr 27, 2012 · OAI

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

Taiwan Three Mast Pharmaceutical Co., Ltd. FDA Warning Letters

1 warning letter on Dec 18, 2012.

Issued	Subject	Issuing office	Close-out letter
Dec 18, 2012

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 Apr 27, 2012.

Date	Site	Product	Classification	FEI
Apr 27, 2012	Tainan City, Taiwan	Drugs	Official Action Indicated (OAI)	3004054758

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 Taiwan Three Mast Pharmaceutical Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 18, 2012.

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 3004054758	Tainan City, Taiwan	1	Apr 27, 2012

Taiwan Three Mast Pharmaceutical Co., Ltd. and the FDA: common questions

Has Taiwan Three Mast Pharmaceutical Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Taiwan Three Mast Pharmaceutical Co., Ltd.. The most recent is dated Dec 18, 2012.

Has Taiwan Three Mast Pharmaceutical Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Taiwan Three Mast Pharmaceutical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Taiwan Three Mast Pharmaceutical Co., Ltd.?

The most recent FDA inspection on file ended Apr 27, 2012 at Tainan City, Taiwan and was classified OAI. FDA has 1 inspection of Taiwan Three Mast Pharmaceutical Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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