Zhejiang Huahai Pharmaceutical Co., Ltd. FDA Record
Zhejiang Huahai Pharmaceutical Co., Ltd. has 0 FDA recalls, 14 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Zhejiang Huahai Pharmaceutical Co., Ltd., the most recent on Jun 6, 2025. FDA has published 5 Form 483s for Zhejiang Huahai Pharmaceutical Co., Ltd..
- Latest inspection
- Apr 24, 2026 · 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 | 14 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 1 | 0 | 0 | 0 |
| 2025 | 1 | 1 | 1 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 2 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 1 | 0 | 0 | 0 |
| 2018 | 1 | 1 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Zhejiang Huahai Pharmaceutical Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jun 6, 2025 · Letter on fda.gov | CGMP/Finished Pharmaceuticals/Adulterated | Office of Manufacturing Quality | |
| Nov 29, 2018 · Record page |
Zhejiang Huahai Pharmaceutical Co., Ltd. Form 483s
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 24, 2026 | Linhai, China | Drugs | Official Action Indicated (OAI) | 3003999190 |
| Jan 24, 2025 | Linhai, China | Drugs | Official Action Indicated (OAI) | 3003999190 |
| Nov 20, 2024 | Linhai, China | Drugs | Voluntary Action Indicated (VAI) | 3003885745 |
| Jul 29, 2021 | Linhai, China | Drugs | No Action Indicated (NAI) | 3003885745 |
| Jul 2, 2021 | Linhai, China | Drugs | No Action Indicated (NAI) | 3003999190 |
| May 31, 2019 | Linhai, China | Drugs | Official Action Indicated (OAI) | 3003999190 |
| Aug 3, 2018 | Linhai, China | Drugs | Official Action Indicated (OAI) | 3003885745 |
| May 19, 2017 | Linhai, China | Drugs | Voluntary Action Indicated (VAI) | 3003885745 |
| Nov 18, 2016 | Linhai, China | Drugs | Voluntary Action Indicated (VAI) | 3003999190 |
| Mar 27, 2015 | Linhai, China | Drugs | No Action Indicated (NAI) | 3003999190 |
| May 23, 2014 | Linhai, China | Drugs | No Action Indicated (NAI) | 3003885745 |
| Aug 9, 2013 | Linhai, China | Drugs | No Action Indicated (NAI) | 3003999190 |
| Sep 8, 2010 | Linhai, China | Drugs | No Action Indicated (NAI) | 3003885745 |
| Sep 2, 2010 | Linhai, China | Drugs | No Action Indicated (NAI) | 3003999190 |
- 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 2 compliance actions under Zhejiang Huahai 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 3003999190 | Linhai, China | 8 | Apr 24, 2026 |
| FEI 3003885745 | Linhai, China | 6 | Nov 20, 2024 |
Zhejiang Huahai Pharmaceutical Co., Ltd. and the FDA: common questions
Has Zhejiang Huahai Pharmaceutical Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 2 warning letters to Zhejiang Huahai Pharmaceutical Co., Ltd.. The most recent is dated Jun 6, 2025, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".
Has Zhejiang Huahai Pharmaceutical Co., Ltd. received an FDA Form 483?
FDA has published 5 Form 483s for Zhejiang Huahai Pharmaceutical Co., Ltd. in its reading room, the most recent dated Apr 24, 2026. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Zhejiang Huahai Pharmaceutical Co., Ltd.?
The most recent FDA inspection on file ended Apr 24, 2026 at Linhai, China and was classified OAI. FDA has 14 inspections of Zhejiang Huahai Pharmaceutical Co., Ltd. on file, 4 of them classified OAI (official action indicated).
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