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Seven Star Pharmaceutical Co., Ltd.

FDA Regulatory Profile

Seven Star Pharmaceutical Co., Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection: Mar 20, 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	5	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Seven Star Pharmaceutical 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	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	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.

Recent FDA inspections

5 inspections from Jan 11, 2013 to Mar 20, 2026.

Date	Site	Product	Classification	FEI
Mar 20, 2026	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002769931
Apr 21, 2023	New Taipei City, Taiwan	Drugs	No Action Indicated (NAI)	3002769931
Jul 6, 2018	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002769931
Apr 29, 2016	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002769931
Jan 11, 2013	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002769931

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.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002769931	New Taipei City, Taiwan	5	Mar 20, 2026

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