Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. FDA Record
- Latest inspection OAI · Mar 22, 2024
- Last warning letter 2024
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.
- Latest inspection
- Mar 22, 2024 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Oct 30, 2024 · Letter on fda.gov | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research (CDER) |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 22, 2024 | Tianjin, China | Drugs | Official Action Indicated (OAI) | 3006283468 |
| Sep 23, 2016 | Tianjin, China | Drugs | Voluntary 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.
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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3006283468 | Tianjin, China | 2 | Mar 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).
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