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Wuxi Medical Lnstrument Factory Co., Ltd. FDA Record

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

Latest inspection OAI · Nov 15, 2024
Last warning letter 2025

Inspections 2

2 OAI

Recalls 1

0 Class I (0%)

Warning letters 2 Latest Apr 4, 2025

510(k) clearances 0 None on file

Wuxi Medical Lnstrument Factory Co., Ltd. has 1 FDA recall, 2 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Wuxi Medical Lnstrument Factory Co., Ltd., the most recent on Apr 4, 2025.

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

Latest recall: D-0247-2025 · Class II · Feb 12, 2025
Latest inspection: Nov 15, 2024 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	1	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	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Wuxi Medical Lnstrument Factory Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Wuxi Medical Lnstrument Factory Co., Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records
2026	0	0	0	0
2025	0	0	1	1
2024	1	1	0	0
2023	0	0	0	0
2022	0	0	0	0
2021	0	0	0	0
2020	0	0	0	0
2019	0	0	0	0
2018	0	0	0	0
2017	1	1	1	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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Wuxi Medical Lnstrument Factory Co., Ltd. FDA Warning Letters

2 warning letters from Sep 7, 2017 to Apr 4, 2025.

Issued	Subject	Issuing office	Close-out letter
Apr 4, 2025 · Record page
Sep 7, 2017 · 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 recalls

1 recall record on Feb 12, 2025.

Number	Class	Product	Date
D-0247-2025	Class II	ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box…	Feb 12, 2025

Recent FDA inspections

2 inspections from Mar 10, 2017 to Nov 15, 2024.

Date	Site	Product	Classification	FEI
Nov 15, 2024	Wuxi, China	Drugs	Official Action Indicated (OAI)	3006851654
Mar 10, 2017	Wuxi, China	Drugs	Official Action Indicated (OAI)	3006851654

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 2 compliance actions under Wuxi Medical Lnstrument Factory Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 4, 2025.

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 3006851654	Wuxi, China	2	Nov 15, 2024

Wuxi Medical Lnstrument Factory Co., Ltd. and the FDA: common questions

Has Wuxi Medical Lnstrument Factory Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Wuxi Medical Lnstrument Factory Co., Ltd.. The most recent is dated Apr 4, 2025.

Has Wuxi Medical Lnstrument Factory Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Wuxi Medical Lnstrument Factory Co., Ltd.?

The most recent FDA inspection on file ended Nov 15, 2024 at Wuxi, China and was classified OAI. FDA has 2 inspections of Wuxi Medical Lnstrument Factory Co., Ltd. on file, 2 of them classified OAI (official action indicated).

Has Wuxi Medical Lnstrument Factory Co., Ltd. had an FDA recall?

Yes. Wuxi Medical Lnstrument Factory Co., Ltd. has 1 FDA recall on record. The most recent started Feb 12, 2025.

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