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Zhuhai Aofute Medical Technology Co., Ltd. FDA Record

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

Zhuhai Aofute Medical Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Zhuhai Aofute Medical Technology Co., Ltd., the most recent on Jan 9, 2020.

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

Latest inspection: Jul 18, 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	1	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

Zhuhai Aofute Medical Technology 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
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	0	0	0
2020	0	0	1
2019	1	1	0
2018	0	0	0
2017	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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Zhuhai Aofute Medical Technology Co., Ltd. FDA Warning Letters

1 warning letter on Jan 9, 2020.

Issued	Subject	Issuing office	Close-out letter
Jan 9, 2020 · 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

1 inspection on Jul 18, 2019.

Date	Site	Product	Classification	FEI
Jul 18, 2019	Zhuhai, China	Drugs	Official Action Indicated (OAI)	3013761135

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

Most recent: Warning Letter, Jan 9, 2020.

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 3013761135	Zhuhai, China	1	Jul 18, 2019

Zhuhai Aofute Medical Technology Co., Ltd. and the FDA: common questions

Has Zhuhai Aofute Medical Technology Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Zhuhai Aofute Medical Technology Co., Ltd.. The most recent is dated Jan 9, 2020.

Has Zhuhai Aofute Medical Technology Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Zhuhai Aofute Medical Technology Co., Ltd.?

The most recent FDA inspection on file ended Jul 18, 2019 at Zhuhai, China and was classified OAI. FDA has 1 inspection of Zhuhai Aofute Medical Technology Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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