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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) FDA Record

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

Latest inspection OAI · Jan 16, 2024
Last warning letter 2024

Inspections 5

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jul 11, 2024

510(k) clearances 0 None on file

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site), the most recent on Jul 11, 2024.

What these totals cover: FDA records filed under the name "Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)".

Latest inspection: Jan 16, 2024 · 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	5	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

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site): FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	1	1	1
2023	0	0	0
2022	0	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	1	0	0
2017	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. (Huanghe Road Site) FDA Warning Letters

1 warning letter on Jul 11, 2024.

Issued	Subject	Issuing office	Close-out letter
Jul 11, 2024 · 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

5 inspections from Jul 26, 2012 to Jan 16, 2024.

Date	Site	Product	Classification	FEI
Jan 16, 2024	Lianyungang, China	Drugs	Official Action Indicated (OAI)	3007373503
May 14, 2018	Lianyungang, China	Drugs	Voluntary Action Indicated (VAI)	3007373503
Nov 2, 2016	Lianyungang, China	Drugs	Voluntary Action Indicated (VAI)	3007373503
May 13, 2014	Lianyungang, China	Drugs	No Action Indicated (NAI)	3007373503
Jul 26, 2012	Lianyungang, China	Drugs	No Action Indicated (NAI)	3007373503

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 Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site): warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 11, 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 3007373503	Lianyungang, China	5	Jan 16, 2024

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) and the FDA: common questions

Has Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site). The most recent is dated Jul 11, 2024.

Has Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) received an FDA Form 483?

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

When did the FDA last inspect Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)?

The most recent FDA inspection on file ended Jan 16, 2024 at Lianyungang, China and was classified OAI. FDA has 5 inspections of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) on file, 1 of them classified OAI (official action indicated).

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