Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site) FDA Record
- Latest inspection NAI · Jan 19, 2024
- No warning letters matched by name
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site) 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. (API Site)" is on file.
- Latest inspection
- Jan 19, 2024 · 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 | 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
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site): FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 19, 2024 | Lianyungang, China | Drugs | No Action Indicated (NAI) | 3007086869 |
| Dec 8, 2017 | Lianyungang, China | Drugs | No Action Indicated (NAI) | 3007086869 |
| Apr 22, 2015 | Lianyungang, China | Drugs | Voluntary Action Indicated (VAI) | 3007086869 |
| Mar 16, 2012 | Lianyungang, China | Drugs | Voluntary Action Indicated (VAI) | 3007086869 |
- 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 3007086869 | Lianyungang, China | 4 | Jan 19, 2024 |
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site) and the FDA: common questions
Has Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site) received an FDA warning letter?
No FDA warning letter addressed to the name "Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site)" 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. (API Site) received an FDA Form 483?
FDA has not published a Form 483 for "Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site)" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site)?
The most recent FDA inspection on file ended Jan 19, 2024 at Lianyungang, China and was classified NAI. FDA has 4 inspections of Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API Site) on file.
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