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Facility profile

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

Testing & analysis · Drug product manufacturing · Jiangsu 222047 · China

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed5 registered company locations
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Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

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Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
Official action indicated (OAI)

Jan 16, 2024 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Jul 2024

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history5 inspection records

FDA inspection history

5 records, Jul 2012 – Jan 2024 · 2 NAI · 2 VAI · 1 OAI

DateClassProject areaCitationsFY
Jan 16, 2024OAIDrug Quality Assurance2024
May 14, 2018VAIDrug Quality Assurance2018
Nov 2, 2016VAIDrug Quality Assurance2017
May 13, 2014NAIDrug Quality Assurance2014
Jul 26, 2012NAIDrug Quality Assurance2012

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Jul 11, 2024Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) — Jiangsu 222047 · China · Labverity