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Henan Kangdi Medical Devices Co. Ltd FDA Record

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

Latest inspection OAI · Mar 7, 2019
Last warning letter 2019

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Dec 3, 2019

510(k) clearances 0 None on file

Henan Kangdi Medical Devices Co. Ltd has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Henan Kangdi Medical Devices Co. Ltd, the most recent on Dec 3, 2019.

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

Latest inspection: Mar 7, 2019 · OAI

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	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Henan Kangdi Medical Devices Co. Ltd FDA Warning Letters

1 warning letter on Dec 3, 2019.

Issued	Subject	Issuing office	Close-out letter
Dec 3, 2019 · Letter on fda.gov		Center for Drug Evaluation and Research

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 Dec 14, 2016 to Mar 7, 2019.

Date	Site	Product	Classification	FEI
Mar 7, 2019	Zhoukou, China	Drugs	Official Action Indicated (OAI)	3009271465
Dec 14, 2016	Zhoukou, China	Drugs	Voluntary Action Indicated (VAI)	3009271465

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

Most recent: Warning Letter, Dec 3, 2019.

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 3009271465	Zhoukou, China	2	Mar 7, 2019

Henan Kangdi Medical Devices Co. Ltd and the FDA: common questions

Has Henan Kangdi Medical Devices Co. Ltd received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Henan Kangdi Medical Devices Co. Ltd. The most recent is dated Dec 3, 2019.

Has Henan Kangdi Medical Devices Co. Ltd received an FDA Form 483?

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

When did the FDA last inspect Henan Kangdi Medical Devices Co. Ltd?

The most recent FDA inspection on file ended Mar 7, 2019 at Zhoukou, China and was classified OAI. FDA has 2 inspections of Henan Kangdi Medical Devices Co. Ltd on file, 1 of them classified OAI (official action indicated).

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