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Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. FDA Record

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

Latest inspection OAI · Dec 8, 2023
Last warning letter 2024

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Aug 1, 2024

510(k) clearances 0 None on file

Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd., the most recent on Aug 1, 2024.

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

Latest inspection: Dec 8, 2023 · 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	2	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

Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	1
2023	1	1	0
2022	0	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	0
2017	1	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.

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Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. FDA Warning Letters

1 warning letter on Aug 1, 2024.

Issued	Subject	Issuing office	Close-out letter
Aug 1, 2024 · Letter on fda.gov	CGMP/Finished Pharmaceuticals/Adulterated	Center for Drug Evaluation and Research (CDER)

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

2 inspections from May 12, 2017 to Dec 8, 2023.

Date	Site	Product	Classification	FEI
Dec 8, 2023	Foshan, China	Drugs	Official Action Indicated (OAI)	3006010954
May 12, 2017	Foshan, China	Drugs	Voluntary Action Indicated (VAI)	3006010954

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 Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 1, 2024.

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 3006010954	Foshan, China	2	Dec 8, 2023

Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. and the FDA: common questions

Has Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.. The most recent is dated Aug 1, 2024, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".

Has Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. received an FDA Form 483?

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

When did the FDA last inspect Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.?

The most recent FDA inspection on file ended Dec 8, 2023 at Foshan, China and was classified OAI. FDA has 2 inspections of Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. on file, 1 of them classified OAI (official action indicated).

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