Zhejiang Chiral Medicine Chemicals Co., Ltd. FDA Record
- Latest inspection VAI · Mar 14, 2025
- No warning letters matched by name
Zhejiang Chiral Medicine Chemicals Co., Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Zhejiang Chiral Medicine Chemicals Co., Ltd." is on file.
- Latest inspection
- Mar 14, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 6 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Zhejiang Chiral Medicine Chemicals Co., Ltd.: 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Hangzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3003878169 |
| Sep 12, 2019 | Hangzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3003878169 |
| Oct 13, 2017 | Hangzhou, China | Drugs | No Action Indicated (NAI) | 3003878169 |
| Aug 11, 2016 | Hangzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3003878169 |
| Jan 29, 2013 | Hangzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3003878169 |
| Aug 19, 2011 | Hangzhou, China | Drugs | Voluntary Action Indicated (VAI) | 3003878169 |
- 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 3003878169 | Hangzhou, China | 6 | Mar 14, 2025 |
Zhejiang Chiral Medicine Chemicals Co., Ltd. and the FDA: common questions
Has Zhejiang Chiral Medicine Chemicals Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Zhejiang Chiral Medicine Chemicals 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 Zhejiang Chiral Medicine Chemicals Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Zhejiang Chiral Medicine Chemicals Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Zhejiang Chiral Medicine Chemicals Co., Ltd.?
The most recent FDA inspection on file ended Mar 14, 2025 at Hangzhou, China and was classified VAI. FDA has 6 inspections of Zhejiang Chiral Medicine Chemicals Co., Ltd. on file.
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