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American Chinese Medicine Association, Inc FDA Record

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

Latest inspection OAI · Jan 20, 2022
Last warning letter 2018

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jun 26, 2018

510(k) clearances 0 None on file

American Chinese Medicine Association, Inc has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to American Chinese Medicine Association, Inc, the most recent on Jun 26, 2018.

What these totals cover: FDA records filed under the name "American Chinese Medicine Association, Inc" and its spelling variant "American Chinese Medicine Association".

Latest inspection: Jan 20, 2022 · 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

American Chinese Medicine Association, Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

American Chinese Medicine Association, Inc: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	1	1	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	1
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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American Chinese Medicine Association, Inc FDA Warning Letters

1 warning letter on Jun 26, 2018.

Issued	Subject	Issuing office	Close-out letter
Jun 26, 2018 · 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 Jan 20, 2022.

Date	Site	Product	Classification	FEI
Jan 20, 2022	Aurora, IL	Drugs	Official Action Indicated (OAI)	3014386146

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 American Chinese Medicine Association, Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 26, 2018.

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 3014386146	Aurora, IL	1	Jan 20, 2022

American Chinese Medicine Association, Inc and the FDA: common questions

Has American Chinese Medicine Association, Inc received an FDA warning letter?

Yes. FDA has issued 1 warning letter to American Chinese Medicine Association, Inc. The most recent is dated Jun 26, 2018.

Has American Chinese Medicine Association, Inc received an FDA Form 483?

FDA has not published a Form 483 for "American Chinese Medicine Association, Inc" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect American Chinese Medicine Association, Inc?

The most recent FDA inspection on file ended Jan 20, 2022 at Aurora, IL and was classified OAI. FDA has 1 inspection of American Chinese Medicine Association, Inc on file, 1 of them classified OAI (official action indicated).

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