Amsino Medical (Kunshan) Co., Ltd. FDA Record
- Latest inspection NAI · Jun 14, 2018
- No warning letters matched by name
Amsino Medical (Kunshan) Co., Ltd. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Amsino Medical (Kunshan) Co., Ltd." is on file.
- Latest inspection
- Jun 14, 2018 · 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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 14, 2018 | Suzhou, China | Devices | No Action Indicated (NAI) | 3005669815 |
| May 12, 2016 | Suzhou, China | Devices | No Action Indicated (NAI) | 3005669815 |
| Sep 12, 2013 | Suzhou, China | Devices | No Action Indicated (NAI) | 3005669815 |
| Nov 4, 2010 | Suzhou, China | Devices | Voluntary Action Indicated (VAI) | 3005669815 |
- 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 3005669815 | Suzhou, China | 4 | Jun 14, 2018 |
Amsino Medical (Kunshan) Co., Ltd. and the FDA: common questions
Has Amsino Medical (Kunshan) Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Amsino Medical (Kunshan) 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 Amsino Medical (Kunshan) Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Amsino Medical (Kunshan) Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amsino Medical (Kunshan) Co., Ltd.?
The most recent FDA inspection on file ended Jun 14, 2018 at Suzhou, China and was classified NAI. FDA has 4 inspections of Amsino Medical (Kunshan) Co., Ltd. on file.
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