Ningbo Luke Medical Devices Co., Ltd. FDA Record
Ningbo Luke Medical Devices Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ningbo Luke Medical Devices Co., Ltd." is on file.
- Latest inspection
- Sep 5, 2019 · 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 | 1 | 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 |
|---|---|---|---|---|
| Sep 5, 2019 | Yuyao City, China | Devices | Voluntary Action Indicated (VAI) | 3013909820 |
- 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 3013909820 | Yuyao City, China | 1 | Sep 5, 2019 |
Ningbo Luke Medical Devices Co., Ltd. and the FDA: common questions
Has Ningbo Luke Medical Devices Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Ningbo Luke Medical Devices 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 Ningbo Luke Medical Devices Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Ningbo Luke Medical Devices Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Ningbo Luke Medical Devices Co., Ltd.?
The most recent FDA inspection on file ended Sep 5, 2019 at Yuyao City, China and was classified VAI. FDA has 1 inspection of Ningbo Luke Medical Devices Co., Ltd. on file.
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