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Changzhou Qianhong Biopharma Co., Ltd. FDA Record

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

Latest inspection VAI · Oct 31, 2025
Last warning letter 2013

Inspections 6

0 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jun 10, 2013

510(k) clearances 0 None on file

Changzhou Qianhong Biopharma Co., Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Changzhou Qianhong Biopharma Co., Ltd., the most recent on Jun 10, 2013.

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

Latest inspection: Oct 31, 2025 · VAI

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

FDA record by year

Changzhou Qianhong Biopharma Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Changzhou Qianhong Biopharma Co., Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	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	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.

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Changzhou Qianhong Biopharma Co., Ltd. FDA Warning Letters

1 warning letter on Jun 10, 2013.

Issued	Subject	Issuing office	Close-out letter
Jun 10, 2013 · Record page

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

6 inspections from Apr 30, 2010 to Oct 31, 2025.

Date	Site	Product	Classification	FEI
Oct 31, 2025	Changzhou, China	Veterinary	Voluntary Action Indicated (VAI)	3005275502
May 10, 2023	Changzhou, China	Drugs	Voluntary Action Indicated (VAI)	3005275502
Oct 23, 2019	Changzhou, China	Drugs	No Action Indicated (NAI)	3005275502
Dec 15, 2017	Changzhou, China	Drugs	Voluntary Action Indicated (VAI)	3005275502
Aug 1, 2014	Changzhou, China	Drugs	Voluntary Action Indicated (VAI)	3005275502
Apr 30, 2010	Changzhou, China	Drugs	No Action Indicated (NAI)	3005275502

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 Changzhou Qianhong Biopharma Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 10, 2013.

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 3005275502	Changzhou, China	6	Oct 31, 2025

Changzhou Qianhong Biopharma Co., Ltd. and the FDA: common questions

Has Changzhou Qianhong Biopharma Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Changzhou Qianhong Biopharma Co., Ltd.. The most recent is dated Jun 10, 2013.

Has Changzhou Qianhong Biopharma Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Changzhou Qianhong Biopharma Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Changzhou Qianhong Biopharma Co., Ltd.?

The most recent FDA inspection on file ended Oct 31, 2025 at Changzhou, China and was classified VAI. FDA has 6 inspections of Changzhou Qianhong Biopharma Co., Ltd. on file.

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