Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. FDA Record

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

  • Latest inspection OAI · Mar 22, 2024
  • Last warning letter 2024
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Oct 30, 2024
510(k) clearances 0 None on file

Tianjin Darentang Jingwanhong Pharmaceutical 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 Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd., the most recent on Oct 30, 2024.

What these totals cover: FDA records filed under the name "Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd." and its spelling variant "Tianjin Darentang Jingwanhong Pharmaceutical Co".

Latest inspection
Mar 22, 2024 · 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

Reviewing Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. 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 Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. 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

Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. FDA Warning Letters

1 warning letter on Oct 30, 2024.

IssuedSubjectIssuing officeClose-out letter
Oct 30, 2024 · Letter on fda.gov CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research (CDER)

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 Sep 23, 2016 to Mar 22, 2024.

DateSiteProductClassificationFEI
Mar 22, 2024Tianjin, ChinaDrugsOfficial Action Indicated (OAI)3006283468
Sep 23, 2016Tianjin, ChinaDrugsVoluntary Action Indicated (VAI)3006283468
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 Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 30, 2024.

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 3006283468Tianjin, China2Mar 22, 2024

Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. and the FDA: common questions

Has Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.. The most recent is dated Oct 30, 2024, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".

Has Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.?

The most recent FDA inspection on file ended Mar 22, 2024 at Tianjin, China and was classified OAI. FDA has 2 inspections of Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. 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.

Get a free API key

Prefer a PDF? Request a free supplier snapshot.

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

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