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Facility profile

Jianerkang Medical Co., Ltd

Testing & analysis · Drug product manufacturing · Changzhou · China

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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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.

AnalysisLabelManufacturePack
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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 21, 2026

Latest matched inspection
No action indicated (NAI)

May 22, 2025 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Past action on file · 2012

More than five years old · review later records.

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Shows

Registration status and a latest matched no action indicated inspection.

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Method and source details
View full inspection and compliance history11 inspection records

FDA inspection history

11 records, Sep 2011 – May 2025 · 3 NAI · 7 VAI · 1 OAI

DateClassProject areaCitationsFY
May 22, 2025NAIPostmarket Assurance: Devices2025
May 22, 2025NAICompliance: Devices2025
Nov 22, 2024VAIDrug Quality Assurance2025
Nov 1, 2019VAIDrug Quality Assurance2020
Mar 9, 2018VAIDrug Quality AssuranceYes2018
Aug 26, 2016NAIDrug Quality Assurance2016
Apr 14, 2016VAICompliance: Devices2016
Apr 14, 2016VAIPostmarket Assurance: Devices2016
Apr 2, 2014VAIDrug Quality AssuranceYes2014
Apr 2, 2014VAICompliance: DevicesYes2014
Sep 19, 2011OAIDrug Quality Assurance2011

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

Matched compliance actions

Jul 30, 2012Warning Letter · CDER
Unclaimed profile

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