Home / Companies / Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory FDA Record

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

Latest inspection VAI · Mar 7, 2025
Last warning letter 2016

Inspections 7

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Aug 4, 2016

510(k) clearances 0 None on file

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory, the most recent on Aug 4, 2016.

What these totals cover: FDA records filed under the name "Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory".

Latest inspection: Mar 7, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	7	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	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	1	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.

Reviewing Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory FDA Warning Letters

1 warning letter on Aug 4, 2016.

Issued	Subject	Issuing office	Close-out letter
Aug 4, 2016 · 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

7 inspections from Mar 11, 2009 to Mar 7, 2025.

Date	Site	Product	Classification	FEI
Mar 7, 2025	Xinchang, China	Drugs	Voluntary Action Indicated (VAI)	3003631275
Nov 30, 2018	Xinchang, China	Drugs	Voluntary Action Indicated (VAI)	3003631275
Jun 30, 2017	Xinchang, China	Drugs	Voluntary Action Indicated (VAI)	3003631275
Jun 18, 2015	Xinchang, China	Drugs	Official Action Indicated (OAI)	3003631275
Jan 17, 2013	Xinchang, China	Drugs	No Action Indicated (NAI)	3003631275
Apr 16, 2010	Xinchang, China	Drugs	Voluntary Action Indicated (VAI)	3003631275
Mar 11, 2009	Xinchang, China	Drugs	No Action Indicated (NAI)	3003631275

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 Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 4, 2016.

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 3003631275	Xinchang, China	7	Mar 7, 2025

Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory and the FDA: common questions

Has Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory. The most recent is dated Aug 4, 2016.

Has Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory received an FDA Form 483?

FDA has not published a Form 483 for "Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory?

The most recent FDA inspection on file ended Mar 7, 2025 at Xinchang, China and was classified VAI. FDA has 7 inspections of Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.