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Jianerkang Medical Co., Ltd. FDA Record

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

Jianerkang Medical Co., Ltd. has 0 FDA recalls, 8 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Jianerkang Medical Co., Ltd., the most recent on Jul 30, 2012.

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

Latest inspection: May 22, 2025 · NAI
Latest 510(k): Dec 15, 2023

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	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	8	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

Jianerkang Medical 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	1	0	0	0	0
2018	1	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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Jianerkang Medical Co., Ltd. FDA Warning Letters

1 warning letter on Jul 30, 2012.

Issued	Subject	Issuing office	Close-out letter
Jul 30, 2012 · 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

8 inspections from Sep 19, 2011 to May 22, 2025.

Date	Site	Product	Classification	FEI
May 22, 2025	Changzhou, China	Devices	No Action Indicated (NAI)	3006403682
Nov 22, 2024	Changzhou, China	Drugs	Voluntary Action Indicated (VAI)	3006403682
Nov 1, 2019	Changzhou, China	Drugs	Voluntary Action Indicated (VAI)	3006403682
Mar 9, 2018	Changzhou, China	Drugs	Voluntary Action Indicated (VAI)	3006403682
Aug 26, 2016	Changzhou, China	Drugs	No Action Indicated (NAI)	3006403682
Apr 14, 2016	Changzhou, China	Devices	Voluntary Action Indicated (VAI)	3006403682
Apr 2, 2014	Changzhou, China	Drugs	Voluntary Action Indicated (VAI)	3006403682
Sep 19, 2011	Changzhou, China	Drugs	Official Action Indicated (OAI)	3006403682

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

Most recent: Warning Letter, Jul 30, 2012.

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 3006403682	Changzhou, China	8	May 22, 2025

Recent 510(k) clearances

1 510(k) clearance on Dec 15, 2023.

K-Number	Device	Date
K232957	Sterile and Non-Sterile Ultrasound Gels	Dec 15, 2023

Jianerkang Medical Co., Ltd. and the FDA: common questions

Has Jianerkang Medical Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Jianerkang Medical Co., Ltd.. The most recent is dated Jul 30, 2012.

Has Jianerkang Medical Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Jianerkang Medical Co., Ltd.?

The most recent FDA inspection on file ended May 22, 2025 at Changzhou, China and was classified NAI. FDA has 8 inspections of Jianerkang Medical Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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