Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) FDA Record
- Latest inspection NAI · Mar 14, 2025
- No warning letters matched by name
Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)" is on file.
- Latest inspection
- Mar 14, 2025 · NAI
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 | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant): FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Wenzhou, China | Drugs | No Action Indicated (NAI) | 3010728912 |
| Mar 22, 2019 | Wenzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3010728912 |
| Jul 22, 2016 | Wenzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3010728912 |
| Dec 20, 2013 | Wenzhou, China | Drugs | No Action Indicated (NAI) | 3010728912 |
| Apr 23, 2009 | Wenzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3010728912 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010728912 | Wenzhou, China | 5 | Mar 14, 2025 |
Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) and the FDA: common questions
Has Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) received an FDA warning letter?
No FDA warning letter addressed to the name "Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) received an FDA Form 483?
FDA has not published a Form 483 for "Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)?
The most recent FDA inspection on file ended Mar 14, 2025 at Wenzhou, China and was classified NAI. FDA has 5 inspections of Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) on file.
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