Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
China See location details
This drug manufacturing facility is registered with the FDA by Zhejiang Jiuzhou Pharmaceutical Co., Ltd..
Facility Inspection History
The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.
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5
Known Inspections
The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.
4
Inspections Found Issues
When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.
- Aug 23, 2024Aug 23, 2024Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Sep 13, 2018Sep 13, 2018Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jul 11, 2016Jul 11, 2016
An import ban on the facility lifted some time after this date.
The FDA doesn't publish a historic record of import alerts, but the last time we saw this facility on archived import bans lists was Jul 11, 2016. - Jan 23, 2016Jan 23, 2016Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 18, 2014Mar 18, 2014Import Ban
The FDA banned the import of medications from this facility.
An import alert was issued for this facility, meaning the FDA had reason to believe products manufactured there violated FDA manufacturing standards and should not be allowed into the country. - Oct 24, 2013Oct 24, 2013Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Apr 21, 2011Apr 21, 2011Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection.