Asymchem Life Science (Tianjin) Co., Ltd. FDA Record
- Latest inspection VAI · Mar 21, 2025
- No warning letters matched by name
Asymchem Life Science (Tianjin) Co., Ltd. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Asymchem Life Science (Tianjin) Co., Ltd." is on file.
- Latest inspection
- Mar 21, 2025 · VAI
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
Asymchem Life Science (Tianjin) 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 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 21, 2025 | Tianjin, China | Drugs | Voluntary Action Indicated (VAI) | 3007060980 |
| Jul 26, 2018 | Tianjin, China | Drugs | No Action Indicated (NAI) | 3007060980 |
| May 22, 2014 | Tianjin, China | Drugs | No Action Indicated (NAI) | 3007060980 |
| May 18, 2011 | Tianjin, China | Drugs | Voluntary Action Indicated (VAI) | 3007060980 |
- 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 3007060980 | Tianjin, China | 4 | Mar 21, 2025 |
Asymchem Life Science (Tianjin) Co., Ltd. and the FDA: common questions
Has Asymchem Life Science (Tianjin) Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Asymchem Life Science (Tianjin) 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 Asymchem Life Science (Tianjin) Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Asymchem Life Science (Tianjin) Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Asymchem Life Science (Tianjin) Co., Ltd.?
The most recent FDA inspection on file ended Mar 21, 2025 at Tianjin, China and was classified VAI. FDA has 4 inspections of Asymchem Life Science (Tianjin) Co., Ltd. on file.
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