Hubei Kangzheng Pharmaceutical Co., Ltd. FDA Record
Hubei Kangzheng Pharmaceutical 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 Hubei Kangzheng Pharmaceutical Co., Ltd., the most recent on Nov 23, 2021.
- Latest inspection
- Jun 24, 2021 · 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 | 1 | 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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Hubei Kangzheng Pharmaceutical Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Nov 23, 2021 · Letter on fda.gov | CGMP/Finished Pharmaceuticals/Adulterated | Center for Drug Evaluation and Research | CDER |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 24, 2021 | Anlu, China | Drugs | Official Action Indicated (OAI) | 3010580682 |
- 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 Hubei Kangzheng 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 3010580682 | Anlu, China | 1 | Jun 24, 2021 |
Hubei Kangzheng Pharmaceutical Co., Ltd. and the FDA: common questions
Has Hubei Kangzheng Pharmaceutical Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Hubei Kangzheng Pharmaceutical Co., Ltd.. The most recent is dated Nov 23, 2021, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".
Has Hubei Kangzheng Pharmaceutical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Hubei Kangzheng Pharmaceutical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hubei Kangzheng Pharmaceutical Co., Ltd.?
The most recent FDA inspection on file ended Jun 24, 2021 at Anlu, China and was classified OAI. FDA has 1 inspection of Hubei Kangzheng Pharmaceutical Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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