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Chang Kuo Chou Pharmaceutical Co., Ltd. FDA Record

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

Latest inspection VAI · Jul 21, 2023
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Chang Kuo Chou Pharmaceutical Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Chang Kuo Chou Pharmaceutical Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Chang Kuo Chou Pharmaceutical Co., Ltd." and its spelling variant "Chang Kuo Chou Pharmaceutical Co".

Latest inspection: Jul 21, 2023 · VAI

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 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Chang Kuo Chou Pharmaceutical Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Chang Kuo Chou Pharmaceutical Co., Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	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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Recent FDA inspections

2 inspections from Sep 8, 2017 to Jul 21, 2023.

Date	Site	Product	Classification	FEI
Jul 21, 2023	Taoyuan City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3007086810
Sep 8, 2017	Taoyuan City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3007086810

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.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007086810	Taoyuan City, Taiwan	2	Jul 21, 2023

Chang Kuo Chou Pharmaceutical Co., Ltd. and the FDA: common questions

Has Chang Kuo Chou Pharmaceutical Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Chang Kuo Chou Pharmaceutical Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Chang Kuo Chou Pharmaceutical Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Chang Kuo Chou Pharmaceutical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Chang Kuo Chou Pharmaceutical Co., Ltd.?

The most recent FDA inspection on file ended Jul 21, 2023 at Taoyuan City, Taiwan and was classified VAI. FDA has 2 inspections of Chang Kuo Chou Pharmaceutical Co., Ltd. on file.

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