Zhejiang Bangli Medical Products Co., Ltd FDA Record

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

  • Latest inspection OAI · Aug 17, 2016
  • Last warning letter 2017
Inspections 1 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Jan 27, 2017
510(k) clearances 0 None on file

Zhejiang Bangli Medical Products Co., Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Zhejiang Bangli Medical Products Co., Ltd, the most recent on Jan 27, 2017.

What these totals cover: FDA records filed under the name "Zhejiang Bangli Medical Products Co., Ltd" and its spelling variant "Zhejiang Bangli Medical Products Co".

Latest inspection
Aug 17, 2016 · OAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Zhejiang Bangli Medical Products Co., Ltd FDA Warning Letters

1 warning letter on Jan 27, 2017.

IssuedSubjectIssuing officeClose-out letter
Jan 27, 2017 · 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 Aug 17, 2016.

DateSiteProductClassificationFEI
Aug 17, 2016Yongkang, ChinaDrugsOfficial Action Indicated (OAI)3007028032
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 Bangli Medical Products Co., Ltd: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 27, 2017.

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 3007028032Yongkang, China1Aug 17, 2016

Zhejiang Bangli Medical Products Co., Ltd and the FDA: common questions

Has Zhejiang Bangli Medical Products Co., Ltd received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Zhejiang Bangli Medical Products Co., Ltd. The most recent is dated Jan 27, 2017.

Has Zhejiang Bangli Medical Products Co., Ltd received an FDA Form 483?

FDA has not published a Form 483 for "Zhejiang Bangli Medical Products Co., Ltd" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Zhejiang Bangli Medical Products Co., Ltd?

The most recent FDA inspection on file ended Aug 17, 2016 at Yongkang, China and was classified OAI. FDA has 1 inspection of Zhejiang Bangli Medical Products 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.