Jiangsu Hansoh Pharmaceutical Group Co., Ltd FDA Record
Jiangsu Hansoh Pharmaceutical Group Co., Ltd has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Jiangsu Hansoh Pharmaceutical Group Co., Ltd" is on file. FDA has published 1 Form 483 for Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
- Latest inspection
- Apr 24, 2026 · OAI
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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 | 4 | 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 1 | 0 | 0 | 0 |
| 2025 | 0 | 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 |
Jiangsu Hansoh Pharmaceutical Group Co., Ltd Form 483s
| Date | Document | FEI |
|---|---|---|
| Apr 24, 2026 | 483 | 3008316144 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 24, 2026 | Lianyungang, China | Drugs | Official Action Indicated (OAI) | 3008316144 |
| Jun 13, 2019 | Lianyungang, China | Drugs | Voluntary Action Indicated (VAI) | 3008316144 |
| Apr 22, 2015 | Lianyungang, China | Drugs | No Action Indicated (NAI) | 3003663251 |
| Mar 16, 2012 | Lianyungang, China | Drugs | Voluntary Action Indicated (VAI) | 3003663251 |
- 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 3008316144 | Lianyungang, China | 2 | Apr 24, 2026 |
| FEI 3003663251 | Lianyungang, China | 2 | Apr 22, 2015 |
Jiangsu Hansoh Pharmaceutical Group Co., Ltd and the FDA: common questions
Has Jiangsu Hansoh Pharmaceutical Group Co., Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "Jiangsu Hansoh Pharmaceutical Group Co., Ltd" 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 Jiangsu Hansoh Pharmaceutical Group Co., Ltd received an FDA Form 483?
FDA has published 1 Form 483 for Jiangsu Hansoh Pharmaceutical Group 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 Jiangsu Hansoh Pharmaceutical Group Co., Ltd?
The most recent FDA inspection on file ended Apr 24, 2026 at Lianyungang, China and was classified OAI. FDA has 4 inspections of Jiangsu Hansoh Pharmaceutical Group Co., Ltd on file, 1 of them classified OAI (official action indicated).
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