Hangzhou Zhongbo Industrial Co., Ltd. FDA Record

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

  • Latest inspection OAI · Apr 27, 2018
  • Last warning letter 2018
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Nov 27, 2018
510(k) clearances 0 None on file

Hangzhou Zhongbo Industrial Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Hangzhou Zhongbo Industrial Co., Ltd., the most recent on Nov 27, 2018.

What these totals cover: FDA records filed under the name "Hangzhou Zhongbo Industrial Co., Ltd." and its spelling variant "Hangzhou Zhongbo Industrial Co".

Latest inspection
Apr 27, 2018 · OAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Hangzhou Zhongbo Industrial Co., Ltd. FDA Warning Letters

1 warning letter on Nov 27, 2018.

IssuedSubjectIssuing officeClose-out letter
Nov 27, 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

2 inspections from Jul 21, 2016 to Apr 27, 2018.

DateSiteProductClassificationFEI
Apr 27, 2018Hangzhou, ChinaDrugsOfficial Action Indicated (OAI)3008229416
Jul 21, 2016Hangzhou, ChinaDrugsVoluntary Action Indicated (VAI)3008229416
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 Hangzhou Zhongbo Industrial Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 27, 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.

FacilityLocationInspectionsLatest
FEI 3008229416Hangzhou, China2Apr 27, 2018

Hangzhou Zhongbo Industrial Co., Ltd. and the FDA: common questions

Has Hangzhou Zhongbo Industrial Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Hangzhou Zhongbo Industrial Co., Ltd.. The most recent is dated Nov 27, 2018.

Has Hangzhou Zhongbo Industrial Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Hangzhou Zhongbo Industrial Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hangzhou Zhongbo Industrial Co., Ltd.?

The most recent FDA inspection on file ended Apr 27, 2018 at Hangzhou, China and was classified OAI. FDA has 2 inspections of Hangzhou Zhongbo Industrial Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.