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Jiangsu Hengrui Pharmaceuticals Co., Ltd. FDA Record

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

Jiangsu Hengrui Pharmaceuticals Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. FDA has issued 1 warning letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd., the most recent on Jul 11, 2024.

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

Latest inspection: Apr 4, 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	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Jiangsu Hengrui Pharmaceuticals 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	1	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	0	0	0	0	0
2018	0	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.

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Jiangsu Hengrui Pharmaceuticals Co., Ltd. FDA Warning Letters

1 warning letter on Jul 11, 2024.

Issued	Subject	Issuing office	Close-out letter
Jul 11, 2024	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 Jan 19, 2024 to Apr 4, 2025.

Date	Site	Product	Classification	FEI
Apr 4, 2025	Lianyungang, China	Drugs	Voluntary Action Indicated (VAI)	3011603969
Jan 19, 2024	Lianyungang, China	Drugs	No Action Indicated (NAI)	3011603969

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 3011603969	Lianyungang, China	2	Apr 4, 2025

Jiangsu Hengrui Pharmaceuticals Co., Ltd. and the FDA: common questions

Has Jiangsu Hengrui Pharmaceuticals Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd.. The most recent is dated Jul 11, 2024, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".

Has Jiangsu Hengrui Pharmaceuticals Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Jiangsu Hengrui Pharmaceuticals Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Jiangsu Hengrui Pharmaceuticals Co., Ltd.?

The most recent FDA inspection on file ended Apr 4, 2025 at Lianyungang, China and was classified VAI. FDA has 2 inspections of Jiangsu Hengrui Pharmaceuticals Co., Ltd. on file.

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