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Lotus Pharmaceutical Co., Ltd.

FDA Regulatory Profile

Lotus Pharmaceutical Co., Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection: Apr 12, 2024 · 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	6	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

Lotus 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	0	0	0	0	0
2025	0	0	0	0	0
2024	1	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.

Recent FDA inspections

6 inspections from Feb 11, 2010 to Apr 12, 2024.

Date	Site	Product	Classification	FEI
Apr 12, 2024	Nan Tou Xian, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3005999589
May 31, 2019	Nan Tou Xian, Taiwan	Drugs	No Action Indicated (NAI)	3005999589
Sep 22, 2017	Nan Tou Xian, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3005999589
Jun 4, 2015	Nan Tou Xian, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3005999589
Aug 16, 2012	Nan Tou Xian, Taiwan	Drugs	No Action Indicated (NAI)	3005999589
Feb 11, 2010	Nan Tou Xian, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3005999589

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 3005999589	Nan Tou Xian, Taiwan	6	Apr 12, 2024

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